FDA Adverse Event
Other
Summary report: N
INSORB SUBCUTICULAR STAPLER
MDR report key: 2092898
·
Received May 5, 2011
Report
- Report Number
- 3004028675-2011-00004
- Event Type
- Other
- Date Received
- May 5, 2011
- Date of Event
- March 28, 2011
- Report Date
- April 13, 2011
- Manufacturer
- INCISIVE SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K090159
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: DEVICE NOT AVAILABLE, INVESTIGATION VIA E-MAIL AND PHONE CORRESPONDENCE WITH SALES REP AND MGR IN SA REGARDING CASE INCLUDING PHOTOS. RESULTS: UNDERLYING SUTURE CLOSURE FAILED. CONCLUSIONS: INSUFFICIENT UNDERLYING SUTURE LAYER STRENGTH PRECIPITATED WOUND SEPARATION. PT IS REPORTED TO BE DOING FINE.
Description of Event or Problem · 1
FOLLOWING TOTAL KNEE ARTHROPLASTY (TKA) SURGERY ON (B)(6) 2011, AN (B)(6) MALE PT, 10 DAYS POST-OP, EXPERIENCED A WOUND SEPARATION FOLLOWED BY AN INFECTION. COMMUNICATION WITH SURGEON INDICATED THE UNDERLYING SUTURES AND STAPLES OVER KNEECAP AREA OPENED UP, HOWEVER; THE AREA ABOVE AND BELOW THE KNEECAP WAS INTACT. THE PT RETURNED TO SURGERY WHERE WOUND WAS DEBRIDED AND SUCCESSFULLY CLOSED WITH SUTURES AND METAL SKIN STAPLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSORB SUBCUTICULAR STAPLER | GDW - STAPLE, IMPLANTABLE | GDW | INCISIVE SURGICAL | 2030 | 103001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | OPSITE BANDAGE AND NECESSARY SUPPORT BANDAGING |