FDA Adverse Event
Malfunction
Summary report: N
SUPERCUT PLASTIC SCS 5-3/4 DEL
MDR report key: 2926496
·
Received January 16, 2013
Report
- Report Number
- 2523190-2013-00002
- Event Type
- Malfunction
- Date Received
- January 16, 2013
- Report Date
- January 16, 2013
- Manufacturer
- INTEGRA YORK, PA INC
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
SCISSORS BROKE WHERE THE BLADE MEETS THE HANDLE. ON (B)(6) 2013, CUSTOMER REPORTS THE DEVICE HAD A VERY CLEAN BREAK DURING AN INGUINAL HERNIA REPAIR WHEN THE DOCTOR WAS DISSECTING TISSUE. NO PARTS LOST IN WOUND. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23857 | SUPERCUT PLASTIC SCS 5-3/4 DEL | N/A | GEI | INTEGRA YORK, PA INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |