FDA Adverse Event
Injury
Summary report: N
V-LOC 90 ABS CLOS DEVICE 7-0 CL 6 P-12
MDR report key: 2618981
·
Received June 12, 2012
Report
- Report Number
- 1219930-2012-00511
- Event Type
- Injury
- Date Received
- June 12, 2012
- Date of Event
- May 7, 2012
- Report Date
- May 16, 2012
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GAM
- PMA / PMN Number
- K100257
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: WHILE SUTURING, THE SUTURE NEEDLE BECAME DISCONNECTED FROM THE SUTURE AND REMAINED IN THE BODY. THIS REQUIRED REOPENING OF THE INCISION TO SEARCH FOR THE NEEDLE AND RECOVER IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-LOC 90 ABS CLOS DEVICE 7-0 CL 6 P-12 | ABSORBABLE BARBED SUTURE | GAM | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | A1L1067X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |