ESTEEM+
Received Jun 26, 2023
Report 1049092-2023-00208 · MDR key 17196971
Device
Generic name
Bag, Urine Collecting, Ureterostomy
Manufacturer
Convatec IncModel number
422545Lot number
0000737544
Product problems
- Malposition of Device
- Malposition of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE RETAILER THAT WAFER HAD OFF CENTERED STARTED HOLE. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
DEVICE 2 OF 3. E1: COMPLAINANT STATE: (B)(6). COMPLAINANT COUNTRY: (B)(6). 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. THIRD PARTY MANUFACTURING SITE (FOR LIFE): 3003759552.