FDA Adverse Event
Malfunction
Summary report: N
INNOMED, INC.
MDR report key: 13583967
·
Received February 23, 2022
Report
- Report Number
- 13583967
- Event Type
- Malfunction
- Date Received
- February 23, 2022
- Date of Event
- February 4, 2022
- Report Date
- February 7, 2022
- Manufacturer
- INNOMED, INC.
- Product Code
- HWB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
ROUNGER WITH AN ANGLED HANDLE HAD A SCREW FALL OUT DURING SURGERY. AN X-RAY WAS TAKEN IMMEDIATELY TO VERIFY THAT NO FOREIGN PIECES FROM THE ROUNGER WERE RETAINED. THE INSTRUMENT WAS THEN REMOVED FROM THE STERILE FIELD.
Description of Event or Problem · 0
ROUNGER WITH AN ANGLED HANDLE HAD A SCREW FALL OUT DURING SURGERY. AN X-RAY WAS TAKEN IMMEDIATELY TO VERIFY THAT NO FOREIGN PIECES FROM THE ROUNGER WERE RETAINED. THE INSTRUMENT WAS THEN REMOVED FROM THE STERILE FIELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 905484 | INNOMED, INC. | EXTRACTOR | HWB | INNOMED, INC. | 1780-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28835 DA | Male |