MalfunctionNAE
DUODERM PASTE AND GELS
Received Apr 3, 2026
Report 1000317571-2026-00079 · MDR key 24776870
Device
Product problems
- Gel Leak
- Delivered as Unsterile Product
- Unsealed Device Packaging
- Device Damaged Prior to Use
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE DISTRIBUTOR REPORTED WHEN THE CUSTOMER RECEIVED THE PRODUCT, THE GEL WAS LEAKING DUE TO DAMAGE TO THE PACKAGE. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Additional Manufacturer Narrative
E1: COMPLAINANT STATE: HYOGO COMPLAINANT COUNTRY: JAPAN 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 NUMBERREPORTING SITE: 1049092MANUFACTURING SITE:1000317571