FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
MDR report key: 4102293
·
Received August 27, 2014
Report
- Report Number
- 8031000-2014-00305
- Event Type
- Malfunction
- Date Received
- August 27, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 21, 2014
- Manufacturer
- ZIMMER SURGICAL S.A.
- Product Code
- HAB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING KIT INSPECTION, THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE WAS IMPOSSIBLE TO TURN OFF. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522686 | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE | HAB | ZIMMER SURGICAL S.A. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |