DUODERM PASTE AND GELS
Received Jun 9, 2026
Report 1000317571-2026-00167 · MDR key 25439650
Device
Generic name
Dressing, Wound, Hydrogel Without Drug And/or Biologic
Manufacturer
Convatec LtdModel number
187987Lot number
5J04334
Product problems
- Delivered as Unsterile Product
- Device Damaged Prior to Use
- Tear, Rip or Hole in Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: COMPLAINANT CITY: (B)(6) COMPLAINANT COUNTRY: PERU NAME OF AFFILIATION:(B)(6) BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 1000317571.
Description of Event or Problem
THE DISTRIBUTOR COMPLAINED REGARDING THE STERILE GEL PRIMARY PACKAGE BROKEN. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.