NATURA
Report
- Report Number
- 9618003-2024-03513
- Event Type
- Malfunction
- Date Received
- September 13, 2024
- Report Date
- August 19, 2024
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- EXE
- UDI-DI
- 00768455187027
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DEVICE 5 OF 7. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE FOR EVALUATION IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). NO SAMPLES WERE AVAILABLE FOR THIS COMPLAINT, AND THEREFORE IT WAS NOT POSSIBLE TO CONFIRM THE COMPLAINT. BATCH RECORD REVISION RESULTS: LOT 4A03047 WAS MANUFACTURED 11 JAN 2024, IN ATS #2 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 23/AUG/2024, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL ID 1222277 AND MANUFACTURING ORDER (B)(4). REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. HISTORICAL COMPLAINTS REVIEW: ON 23/AUG/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 4A03047 LOT FOR THE INTEGRAL WELD OF OUTLINE / SLEEVE IS DEFECTIVE AND/OR SEPARATES, LEAKAGE MAY OCCUR DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 23/AUG/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) ASSOCIATED TO INTEGRAL WELD OF OUTLINE / SLEEVE IS DEFECTIVE AND/OR SEPARATES, LEAKAGE MAY OCCUR DEFECT FOR THE LOT NUMBER 4A03047 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA ) WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN SEVEN DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4), WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS DEFECT WHICH SHOULD BE 0.25% BASED ON OUR DR-STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE UNIT, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 0.25. TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: AS NO PHOTOGRAPHS OR SAMPLES WERE AVAILABLE FOR THIS COMPLAINT ISSUE, IT WAS NOT POSSIBLE TO RAISE AN INVESTIGATION FOR THE ISSUE REPORTED. A BATCH RECORD REVIEW WAS COMPLETED AND SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). 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.
MDR CORRECTION: - THIS EMDR IS BEING SUBMITTED FOR THE CORRECTION OF INVESTIGATION RESULTS THAT WERE SUBMITTED IN THE INITIAL EMDR TW (B)(4) WITH PATIENT ID (B)(6) (MFG REPORT NUMBER 9618003-2024-02743). PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE FOR EVALUATION IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). NO SAMPLES WERE AVAILABLE FOR THIS COMPLAINT, AND THEREFORE IT WAS NOT POSSIBLE TO CONFIRM THE COMPLAINT. BATCH RECORD REVISION RESULTS: LOT 4A03047 WAS MANUFACTURED 1/11/2024, IN ATS #2 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 23/AUG/2024, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL ID 1222277 AND MANUFACTURING ORDER (B)(4). REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. HISTORICAL COMPLAINTS REVIEW: ON 23/AUG/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 4A03047 LOT FOR THE SKIN BARRIER MIGRATES AND OBSTRUCTS STOMA DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 23/AUG/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) ASSOCIATED TO THE SKIN BARRIER MIGRATES AND OBSTRUCTS STOMA DEFECT FOR THE LOT NUMBER 4A03047 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA ) WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN SEVEN DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4), WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS DEFECT WHICH SHOULD BE (B)(4) BASED ON OUR DR-STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE UNIT, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF (B)(4). TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: AS NO PHOTOGRAPHS OR SAMPLES WERE AVAILABLE FOR THIS COMPLAINT ISSUE, IT WAS NOT POSSIBLE TO RAISE AN INVESTIGATION FOR THE ISSUE REPORTED. A BATCH RECORD REVIEW WAS COMPLETED AND SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). 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.
THE CONSUMER REPORTED THAT THE OPENING AROUND HER STOMA HAD BEEN DETERIORATING RAPIDLY. PREVIOUSLY, SHE COULD WEAR IT FOR FOUR TO FIVE DAYS, BUT SHE HAD TO START CHANGING IT AFTER JUST ONE DAY. THE OPENING BECAME SOFT AND MUSHY, AND SHE FOUND PIECES OF THE MATERIAL IN THE BAG. ON THREE OCCASIONS, THE OPENING CLOSED AROUND THE STOMA, BLOCKING THE URINE FLOW. ABOUT A MONTH AGO, SHE EXPERIENCED SEVERE BACK PAIN AND VISITED HER DOCTOR, SUSPECTING A KIDNEY PROBLEM, BUT IT TURNED OUT NOT TO BE THE CASE. ON (B)(6) 2024, WHILE LYING DOWN, SHE FELT THE BACK PAIN AGAIN AND NOTICED THAT HER NIGHT BAG HAD NO URINE AFTER FIVE HOURS. THE OPENING HAD BLOCKED THE STOMA. SHE CONTINUED TO USE THE PRODUCT. AFTER CHANGING HER WAFER, THE URINE FLOWED INTO THE POUCH AGAIN. SHE MENTIONED THAT SHE MOLDED THE OPENING TO FIT HER STOMA AND DID NOT BELIEVE IT WAS A SIZING ISSUE SINCE THERE WAS NO LEAKAGE. IN HER OPINION, THERE WAS SOMETHING WRONG WITH THIS BOX. NO PHOTO WAS AVAILABLE AT THIS TIME.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1207794 | NATURA | PROTECTOR, OSTOMY | EXE | CONVATEC DOMINICAN REPUBLIC INC | 411802 | 4A03047 | 00768455187027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female |