FDA Adverse Event
Injury
Summary report: N
APPOSE ULC 35 REGULAR SKIN STAPLER
MDR report key: 3854875
·
Received May 22, 2014
Report
- Report Number
- 9612501-2014-00157
- Event Type
- Injury
- Date Received
- May 22, 2014
- Date of Event
- April 1, 2014
- Report Date
- May 1, 2014
- Manufacturer
- COVIDIEN
- Product Code
- GDT
- PMA / PMN Number
- K900486
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: SKIN CLOSURE. ACCORDING TO THE REPORTER: WHEN APPLYING SKIN GRAFTS ON A BURNS PT, THE STAPLER FAILED TO RELEASE THE STAPLES, ATTACHING THE DEVICE TO TISSUE AND CREATING TISSUE TRAUMA. THERE WAS NO UNANTICIPATED TISSUE LOSS AND NO ADD'L BLOOD LOSS OVER 500 CC. HOWEVER, THERE WAS AN EXTENSION IN SURGERY BY MORE THAN 30 MINUTES, RESULTING IN LOSS OF SKIN GRAFTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306974 | APPOSE ULC 35 REGULAR SKIN STAPLER | DISPOSABLE SURGICAL STAPLER | GDT | COVIDIEN | J3G0305X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |