NATURA
Received Jun 11, 2026 · Event occurred May 17, 2026
Report 9618003-2026-01039 · MDR key 25466883
Device
Generic name
Protector, Ostomy
Manufacturer
Convatec Dominican Republic IncModel number
404592Lot number
4G04849
Product problems
- Material Too Rigid or Stiff
Patient
Not reported
- Discomfort
Narrative
Additional Manufacturer Narrative
DEVICE 1 OF 2. (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: 9618003.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE SKIN BARRIER WAS TOO STIFF, RESULTING IN DISCOMFORT AROUND THE STOMA. THE ISSUE WAS OBSERVED WITH TWO SKIN BARRIERS, AND A VIDEO DEPICTING THE CONCERN WAS RECEIVED.