FDA Adverse Event
Other
Summary report: N
ETHICON ETHILON NYLON SUTURE
MDR report key: 20470730
·
Received October 16, 2024
Report
- Report Number
- MW5161109
- Event Type
- Other
- Date Received
- October 16, 2024
- Report Date
- October 9, 2024
- Manufacturer
- ETHICON, INC.
- Product Code
- GAR
- Report Source
- Voluntary report
- Reporter Occupation
- 501
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
SURGEON REPORTED THAT TWO NYLON SUTURES (BOTH ETHICON REF #1667G) IN DIFFERENT CASES ON THE SAME DAY BROKE WITH THE KNOTS INTACT. THE BREAKS RESULTED IN ONE OF THE PATIENT'S WOUNDS OPENING UP. REF REPORT: MW5161108.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2270899 | ETHICON ETHILON NYLON SUTURE | SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE | GAR | ETHICON, INC. | 1667G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |