Product Reporting

Report an Issue or Product Concern

At HARPS Global, product safety and customer trust are our top priorities. If you have experienced an allergic reaction, product performance issue, or any other safety concern related to our gloves or protective equipment, please review the below information on how to submit a report. Your report helps our team investigate the matter thoroughly and maintain the highest standards of quality and compliance.

Important Notice: This information is intended solely for reporting product safety concerns or performance issues related to HARPS Global products. It is not intended for medical emergencies. If you are experiencing a medical emergency, please contact your healthcare provider or emergency services immediately. Information submitted will be reviewed by our Compliance team in accordance with applicable regulatory requirements. Submission of this form does not constitute an admission of liability and does not guarantee compensation, reimbursement, or a specific outcome.

Claim Handling

Because of evolving global medical device regulations, the claim handling process has become increasingly important – not only for us as a manufacturer, but also for you as our distribution partners and end users. Regulatory frameworks worldwide require medical device manufacturers to report adverse events and Field Safety Corrective Actions (FSCAs) to the relevant national competent authorities.

In addition, there is a growing global emphasis on post-market surveillance, which includes the systematic handling of complaints as well as the identification and reporting of safety-related events.

To ensure a smooth and structured process, we kindly ask you to include the following information when submitting a claim.  Incomplete information may delay investigation and regulatory assessment.

For end users

• Reporter data 
  • Name and contact details of reporting person 
  • Facility / hospital name (if applicable) 

• Glove type incl. glove size (e.g., sempermed^® Supreme size 7.5)

• Exact description of observed defect (e.g., hole in the glove, location, size)

• When was defect detected? (before use / during use / after use) 

• Was defect isolated or systematic? (single glove / multiple gloves) 

• Packaging condition (intact/damaged before opening) 

• Type of procedure 

• Any unusual conditions (e.g., long wear time, double gloving, disinfectant exposure) or observations 

• LOT number (include complete number on dispenser, e.g., for exam: C25030097; surgical: 26 A 0211)

• Please provide amount of defective product (include if applicable your company specific claim number for this case)

• If applicable the distribution partner from whom you bought the product

• Was the product used on patient (yes/no)

• Detailed event description (chronological), what happened during use? 

• Clinical outcome (no harm / temporary harm / serious deterioration) 

• Was medical treatment required? (yes/no, if yes specify) 

• Event reported to authority (yes/no)

• In case of any adverse skin reaction (e.g. irritation, allergy, hypersensitivity) please provide a filled out copy of the Skin Irritation Questionnaire

• Pictures of defective dispenser boxes and/or glove

• Samples of the affected gloves for root cause investigation (please include original packaging and do not clean or alter samples)

For distributors

• Ensure completeness of incoming claims (items on above list must be included)

• Please contact your local HARPS representative as to where and how to ship the glove samples for complaints

• Claim notifications and the subsequent shipment of samples are required to be made in a timely manner

• Any incident involving potential patient or user harm must be reported immediately (within 24 hours)
• Confirmation that the storage and transportation conditions were met, or information on actual storage and transport conditions if deviations are suspected

For Transportation damages

• Delivery Note with Clear Damage Remarks

  • Damage must be clearly stated upon receipt

  • Document must be stamped / signed

• CMR with Customer Damage Remarks

  • Must explicitly describe the received damage

  • Must be must be stamped / signed

• Photo Documentation

  • Photos must match the number of damaged cartons

  • Example: If 20 cartons are damaged, multiple photos must clearly show damage to all 20 cartons

Please provide all  necessary information so we can process your request as soon as possible.

Based on your region, review the contact information below to submit a report, or reach out to your local sales representative.