MalfunctionEXE
NATURA
Received Apr 17, 2026
Report 9618003-2026-00733 · MDR key 24906984
Device
Generic name
Protector, Ostomy
Manufacturer
Convatec Dominican Republic IncModel number
401902Lot number
5E02635
Product problems
- Complete Blockage
- Material Protrusion/Extrusion
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE END USER REPORTED THAT THE MASS BECAME TOO SWOLLEN AND BLOCKED THE STOMA. NO PHOTO WAS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
DEVICE 3 OF 5. E1: (B)(6). 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 NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.