GUT PL FAG UD 18IN 5-0 S/A PC-1 PRM MP
Report
- Report Number
- 2210968-2024-04359
- Event Type
- Malfunction
- Date Received
- April 16, 2024
- Date of Event
- February 23, 2024
- Report Date
- May 22, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- GAL
- UDI-DI
- 10705031002913
- PMA / PMN Number
- K946173
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT: (B)(4). DATE SENT TO THE FDA: 5/22/2024. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: IT WAS REPORTED THAT "WHILE ATTEMPTING TO SUTURE PATIENT'S FOREHEAD, SUTURE MATERIAL REPEATEDLY BROKE APART" PLEASE CONFIRM THE NUMBER OF SUTURES THAT BROKE DURING THIS PROCEDURE. UNKNOWN; SUTURES WERE PLACED BUT AS THE NEXT ONE WAS BEING PLACED, THE LAST SUTURE WOULD SPLIT APART. IS THIS DEVICE OR SAMPLES AVAILABLE FOR ANALYSIS? IF YES, TO WHOM SHOULD THE SHIPPER KIT BE SENT? (PLEASE PROVIDE CONTACT NAME, DEPARTMENT, STREET ADDRESS INCLUDING ZIP, NO PO BOX PLEASE, EMAIL ADDRESS, AND PHONE NUMBER) YES AND NO. I DO NOT HAVE THE ACTUAL SUTURES, BUT I DO HAVE THE REMAINING BOX OF SUTURES. PLEASE SEND SHIPPER KIT TO: (B)(6). PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) (B)(6) , RISK & CLAIMS ANALYST. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
(B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IT WAS REPORTED THAT "WHILE ATTEMPTING TO SUTURE PATIENT'S FOREHEAD, SUTURE MATERIAL REPEATEDLY BROKE APART" * PLEASE CONFIRM THE NUMBER OF SUTURES THAT BROKE DURING THIS PROCEDURE. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. RELATED EVENTS CAPTURED VIA: 2210968-2024-04359 2210968-2024-04360.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE APART WHILE ATTEMPTING TO SUTURE PATIENT'S FOREHEAD. CHANGED TO ANOTHER ONE BUT THE SAME THING HAPPENED AGAIN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1125776 | GUT PL FAG UD 18IN 5-0 S/A PC-1 PRM MP | SUTURE, ABSORBABLE, NATURAL | GAL | ETHICON INC. | TKMACZ | 10705031002913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |