FDA Adverse Event
Other
Summary report: N
INSORB
MDR report key: 1102144
·
Received August 4, 2008
Report
- Report Number
- 3004028675-2008-00006
- Event Type
- Other
- Date Received
- August 4, 2008
- Date of Event
- July 12, 2008
- Report Date
- August 1, 2008
- Manufacturer
- INCISIVE SURGICAL, INC.
- Product Code
- GDW
- PMA / PMN Number
- K061784
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INSORB SUBCUTICULAR STAPLER HAS BEEN USED SUCCESSFULLY TO CLOSE HIP REPLACEMENT INCISIONS AT NUMEROUS FACILITIES PRIOR TO THIS INCIDENT. WE SUSPECT THAT PT CONDITIONS, SUCH AS OBESITY, PLAYED A ROLE IN THE OPERATIONAL CONTEXT OF THIS CASE.
Description of Event or Problem · 1
A FEMALE PT EXPERIENCED A SMALL WOUND DISRUPTION APPROXIMATELY 11 DAYS FOLLOWING HIP REPLACEMENT SURGERY. THE PT WAS TAKEN TO THE OR AND THE INCISION WAS CLOSED WITH METAL SKIN STAPLES UNDER GENERAL ANESTHESIA. THERE WAS NO INFECTION NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSORB | GDW-STAPLE, IMPLANTABLE | GDW | INCISIVE SURGICAL, INC. | INSORB 25 | 080101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |