L3O0200 - NATURA
Report
- Report Number
- 9618003-2021-00083
- Event Type
- Malfunction
- Date Received
- January 27, 2021
- Report Date
- December 30, 2020
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- EXE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER
Narratives
CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(4). NO SAMPLE, VIDEO OR PHOTO WAS RECEIVED FOR EVALUATION; FOR THAT REASON, THE MALFUNCTION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. LOT 0K02670 WAS MANUFACTURED ON 10/23/2020 IN THE MLK-3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. ON 01/JUN/2021, COMPLIANCE ENGINEER ID 6053 PERFORMED A BATCH RECORD REVIEW, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM, UNDER SAP MATERIAL 1159898, ICC CODE 413156 AND MANUFACTURING ORDER (B)(4). THE CREW REQUIREMENTS AND RESPONSIBILITIES, PROCESS PARAMETERS, QUALITY AND IN-PROCESS INSPECTIONS, LINE OPERATIONS, PROCESS TROUBLESHOOTING AND RELEVANT DOCUMENTS TO THE PROCESS WERE RUN ACCORDING THE PROCESS INSTRUCTION PI31-113. THE PROCESS REQUIREMENTS RESULTS WERE DOCUMENTED IN THE MANUFACTURING RECORD BR31-113. IN ADDITION, THE BATCH RECORD OF BULK LOTS 0K02449 AND 0K02448, MANUFACTURED IN THE ELC7 MANUFACTURING LINE, WERE REVIEWED AND NO ISSUES WERE FOUND; THE LOT RAN ACCORDING TO SAP MATERIAL 1014164 AND ALL THE TESTING RESULTS WERE FOUND SATISFACTORY. THE PROCESS WAS RUN ACCORDING TO PROCESS INSTRUCTION PI31-018, DOCUMENTED IN MR31-018. BATCH RECORD REVIEW SUPPORTS THAT NO ISSUES REGARDING THE FAILURE MODE REPORTED WERE IDENTIFIED. ON 01/JUN/2021 A COMPLAINT SEARCH FOR LOT 0K02670 AND MALFUNCTION CODE OST-PMC1.12 / OST-PMC01.12 SKIN BARRIER MIGRATES AND OBSTRUCTS STOMA WAS CARRIED OUT AND AS A RESULT, NO ADDITIONAL COMPLAINTS WERE FOUND; THEREFORE, NO POTENTIAL TREND IS OBSERVED. AS PER COMPLAINT MANUFACTURING INVESTIGATION PROCEDURE WI-0359, VERSION 5.0, IT IS NOT REQUIRED TO OPEN A NONCONFORMANCE REPORT (NCR) FOR TYPE 2 COMPLAINTS WHICH WERE NOT CONFIRMED (EITHER BY PHOTO, VIDEO OR SAMPLE PROVIDED BY THE CUSTOMER, OR AS A RESULT OF THE BATCH RECORD REVIEW) AND NO POTENTIAL TREND IS IDENTIFIED. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
DEVICE 1 OF 7. 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. (B)(4).
THE END USER REPORTED THAT AN UNKNOWN NUMBER OF WAFERS OUT OF BOX OF 10 WAFERS, BECAME "MELTY" IN THE CENTER WITHIN 1-2 DAYS OF APPLICATION, AND PARTIALLY COVERED OVER THE STOMA. THE END USER'S DAUGHTER SUSPECTS "6 OR 7" AFFECTED WAFERS. SHE STATED THAT THE STOOL APPEARED TO HAVE DIFFICULTY COMING INTO THE POUCH AND HER MOTHER HAD DISCOMFORT AS A RESULT. SHE CHANGED THE APPLIANCE FOR HER MOTHER AND THE DISCOMFORT RESOLVED. HER USUAL WEAR TIME WAS 2 DAYS, BUT WITH AFFECTED POUCHES SHE HAD CHANGED WITHIN 1-2 DAYS. SHE HAD USED THESE WAFERS PRIOR TO THIS BOX AND DID NOT HAVE ANY ISSUES. SHE DENIED CURRENT LEAKAGE OR SKIN IRRITATION. NO PHOTO AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134711 | L3O0200 - NATURA | PROTECTOR, OSTOMY | EXE | CONVATEC DOMINICAN REPUBLIC INC | 413156 | 0K02670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |