FDA Adverse Event
Injury
Summary report: N
UNK POLYSORB SUTURE
MDR report key: 2895362
·
Received November 30, 2012
Report
- Report Number
- 1219930-2012-00954
- Event Type
- Injury
- Date Received
- November 30, 2012
- Date of Event
- August 17, 2012
- Report Date
- October 26, 2012
- Manufacturer
- COVIDIEN, FORMERLY UNITED STATES
- Product Code
- GAM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAMINECTOMY. ACCORDING TO THE REPORTER: THE PT EXPERIENCED A SUDDEN POP, AND IT WAS DISCOVERED THAT THE WOUND HAS DETACHED WITH THE SUTURES BROKEN COMPLETELY DOWN TO THE CERVICAL SPINE. THE PT REMAINED AFEBRILE AND THERE WAS NO APPARENT PURULENCE. CLOSED WOUND, INITIAL SURGERY SUTURE FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK POLYSORB SUTURE | UNK POLYSORB SUTURE | GAM | COVIDIEN, FORMERLY UNITED STATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |