FDA Adverse Event
Malfunction
Summary report: N
INNOMED
MDR report key: 14074311
·
Received April 11, 2022
Report
- Report Number
- 1833053-2022-00002
- Event Type
- Malfunction
- Date Received
- April 11, 2022
- Date of Event
- February 16, 2022
- Report Date
- April 4, 2022
- Manufacturer
- INNOMED INC.
- Product Code
- GAD
- UDI-DI
- 00840277118981
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
RECEIVED NOTIFICATION FROM CUSTOMER AND REQUESTED THAT THE DEVICE BE SENT IN FOR EVALUATION. CUSTOMER AGREED. WAITING TO RECEIVE THE DEVICE. WILL PROVIDE RESULTS OF EVALUATION IN FOLLOW UP REPORT.
Description of Event or Problem · 0
FOR A FRACTURED LEFT HIP, A HOHMANN RETRACTOR WQAS USEF. THE TIP WS WEAK AND IT BENT. THIS WAS A RADIOLUCENT RETRACTOR, A KIND THAT IS NOT NORMALLY KEPT IN THE HIP SET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1072610 | INNOMED | HOHMANN RETRACTOR ORTHOLUCENT SQUARE TIP 16MM | GAD | INNOMED INC. | 4558-R | 0916GSL | 00840277118981 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male |