FDA Adverse Event
Malfunction
Summary report: N
PROLENE POLYPROPYLENE SUTURE
MDR report key: 166793
·
Received May 8, 1998
Report
- Report Number
- 2210968-1998-00161
- Event Type
- Malfunction
- Date Received
- May 8, 1998
- Date of Event
- April 8, 1998
- Report Date
- April 8, 1998
- Manufacturer
- ETHICON, INC.
- Product Code
- GAW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SUTURE BREAKAGE: CUSTOMER REPORTS THAT SUTURE BROKE DURING CABG PROCEDURE. THERE ARE NO REPORTED ADVERSE CONSEQUENCES TO THE PT RELATED TO THIS EVENT. NOTE: OUTCOME TO PT DOES NOT DENOTE ADVERSE EVENT. MDR REGULATION OF 07/31/96 REQUIRES REPORTING OF INCIDENT ONCE MEDICAL DEVICE FAMILY INITIALLY REPORTED ASSUMING INCIDENT COULD RECUR. ETHICON INC'S INTERNAL CONTROL NUMBER IS: 9800325-00.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLENE POLYPROPYLENE SUTURE Implant | NON-ABSORBABLE SUTURE | GAW | ETHICON, INC. | NA | LAE888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |