FDA Adverse Event
Other
Summary report: N
SUTURE NEEDLE
MDR report key: 27780
·
Received November 2, 1995
Report
- Report Number
- MW1007552
- Event Type
- Other
- Date Received
- November 2, 1995
- Date of Event
- October 26, 1995
- Report Date
- October 26, 1995
- Manufacturer
- ETHICON, INC.
- Product Code
- GAB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING AN ENT PROCEDURE IN THE ORAL CAVITY, THE SUTURE NEEDLE BROKE AND THE NEEDLE COULD NOT BE RETRIEVED FROM THE OPERATIVE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUTURE NEEDLE | SUTURE NEEDLE | GAB | ETHICON, INC. | 2-0 J-417 | HA9345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Other |