FDA Adverse Event
Other
Summary report: N
INSORB SUBCUTICULAR STAPLER
MDR report key: 2240609
·
Received August 26, 2011
Report
- Report Number
- 3004028675-2011-00011
- Event Type
- Other
- Date Received
- August 26, 2011
- Date of Event
- July 25, 2011
- Report Date
- August 24, 2011
- Manufacturer
- INCISIVE SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K090159
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT INVESTIGATION HAS YIELDED LITTLE INFO ABOUT THIS CASE, THE PT, AND THE SPECIFICS ABOUT THE INCIDENT. THE DEVICE USED IN THE CASE WAS NOT AVAILABLE FOR EXAMINATION.
Description of Event or Problem · 1
A MALE, PT, UNDERWENT A COLORECTAL PROCEDURE AND THE INSORB STAPLER WAS USED TO CLOSE A 25 CM HIGH TENSION, PRIMARY INCISION. TWO DAYS POST OP, THE PT EXPERIENCED A PARTIAL, 8 CM WOUND SEPARATION. THE SEPARATION WAS RE-CLOSED UNDER LOCAL ANESTHETIC USING 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | DEEP DERMAL SUTURE| STERI-STRIPS |