L3O0675 - ESTEEM+
Report
- Report Number
- 9618003-2021-02927
- Event Type
- Malfunction
- Date Received
- December 29, 2021
- Report Date
- November 29, 2021
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- EZQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
DEVICE 2 OF 2. COMMON DEVICE NAME: POUCH, COLOSTOMY. PRODUCT CODE: EZQ. COMPLAINANT STATE: (B)(6). EVENT COUNTRY: (B)(6). CORRECTION - CONTACT OFFICE ADDRESS: (B)(4). PMA /510(K) #: EXEMPT. 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 (B)(4).
DEVICE 2 OF 2. COMMON DEVICE NAME: POUCH, COLOSTOMY. PRODUCT CODE: EZQ. COMPLAINANT STATE: (B)(6). EVENT COUNTRY: (B)(6). CORRECTION - CONTACT OFFICE ADDRESS: (B)(4). PMA /510(K) #: EXEMPT. 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 (B)(4).
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
IT WAS REPORTED THAT, THE WAFER WITH STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
IT WAS REPORTED THAT, THE WAFER WITH STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2000898 | L3O0675 - ESTEEM+ | EZQ | CONVATEC DOMINICAN REPUBLIC INC | 421022 | 1B03448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |