FDA Adverse Event
Injury
Summary report: N
VLOC 90 2/0 VL 6 GS-22
MDR report key: 3854903
·
Received May 28, 2014
Report
- Report Number
- 1219930-2014-00409
- Event Type
- Injury
- Date Received
- May 28, 2014
- Date of Event
- April 22, 2014
- Report Date
- April 29, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K100257
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE SUTURE NEEDLE CAN BE SEEN DURING THE SURGICAL PROCEDURE. DURING THE PROCEDURE, THE NEEDLE DETACHED AND REMAINS IN THE ABDOMINAL WALL, WITHOUT FRICTION OR HARM TO THE PT. THE NEEDLE IS LOCATED IN THE ABDOMINAL WALL OF THE PT AS SEEN USING FLUOROSCOPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 315136 | VLOC 90 2/0 VL 6 GS-22 | VLOC SUTURE | GAM | COVIDIEN, FORMERLY US SURGICAL | A3A0501X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other |