FDA Adverse Event
Injury
Summary report: N
POLYSORB 2/0 30 UNDYED HOS-11
MDR report key: 3143096
·
Received May 24, 2013
Report
- Report Number
- 1219930-2013-00400
- Event Type
- Injury
- Date Received
- May 24, 2013
- Report Date
- April 28, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- GAM
- PMA / PMN Number
- K963253
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: KNEE REPLACEMENT. ACCORDING TO THE REPORTER: THE SURGEON STATED THAT THE PT INCISION HAD SOME DEHISCENCE AND WAS SPLITTING AT THE SURGICAL SITE. THE DIFFICULTY DID NOT RESULT IN UNINTENDED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT OR COMPONENT FELL INTO THE PT'S CAVITY. NO DEVICE FRAGMENT OR COMPONENT WAS LEFT IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231658 | POLYSORB 2/0 30 UNDYED HOS-11 | POLYSORB | GAM | COVIDIEN, FORMERLY US SUR | A2L056SX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |