FDA Adverse Event
Injury
Summary report: N
V-LOC 180 ABS CLOS DEVICE 3-0 GR 6 V-20
MDR report key: 4102546
·
Received September 16, 2014
Report
- Report Number
- 1219930-2014-00833
- Event Type
- Injury
- Date Received
- September 16, 2014
- Date of Event
- August 18, 2014
- Report Date
- August 25, 2014
- Manufacturer
- COVIDIEN, FORMERLY US
- Product Code
- GAM
- PMA / PMN Number
- K091087
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: GYNECOLOGY. ACCORDING TO THE REPORTER: HYSTEROSCOPY/LAPAROSCOPY/MYOMECTOMY/ADHESIOLYSIS. THE NEEDLE WAS ON THE END OF THE V-LOC, IT WAS PLACED INSIDE PORT AND IT FELL OFF AND DISAPPEARED IN THE ABDOMINAL CAVITY. THE SUTURE HADN'T BEEN USED ON THE PATIENT AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572138 | V-LOC 180 ABS CLOS DEVICE 3-0 GR 6 V-20 | V-LOC | GAM | COVIDIEN, FORMERLY US | A4C0589VX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |