FDA Adverse Event
Injury
Summary report: N
POLYSORB 2 36 VIOLET KV-40
MDR report key: 2090120
·
Received May 6, 2011
Report
- Report Number
- 1219930-2011-00374
- Event Type
- Injury
- Date Received
- May 6, 2011
- Date of Event
- November 15, 2010
- Report Date
- April 20, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K963253
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE THREAD USED FOR CLOSING WOUND EDGES BROKE AND THE PT HAD TO BE RE-OPERATED ON. THE THREAD BROKE IN THE MIDDLE AND NOT AT THE KNOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYSORB 2 36 VIOLET KV-40 | ABSOBABLE SUTURE PRODUCT | GAM | UNITED STATES SURGICAL | A0E1279F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |