FDA Adverse Event
Malfunction
Summary report: N
GRASPER, ALLIGATOR 2.7MM UPCURVED
MDR report key: 1651699
·
Received April 2, 2010
Report
- Report Number
- 1219602-2010-00069
- Event Type
- Malfunction
- Date Received
- April 2, 2010
- Date of Event
- March 2, 2010
- Report Date
- March 2, 2010
- Manufacturer
- MANSFIELD MANUFACTURING SITE
- Product Code
- NBH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. (B) (4)
Description of Event or Problem · 1
DURING THE SURGERY, THE DOCTOR WENT TO BITE A LOOSE BODY AND THE JAW BROKE OFF. IT TOOK TWO HOURS TO RETRIEVE THE PIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GRASPER, ALLIGATOR 2.7MM UPCURVED | GRASPER, ALLIGATOR 2.7MM UPCURVED / NBH | NBH | MANSFIELD MANUFACTURING SITE | 011021 | 50052769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |