FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL BONE GROWTH STIMULATOR
MDR report key: 859697
·
Received May 15, 2007
Report
- Report Number
- 2183449-2007-00008
- Event Type
- Malfunction
- Date Received
- May 15, 2007
- Date of Event
- April 20, 2007
- Report Date
- May 15, 2007
- Manufacturer
- ORTHOFIX INC.
- Product Code
- LOF
- PMA / PMN Number
- P850007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IN QUESTION WILL NOT BE RETURNED TO ORTHOFIX INC. FOR EVALUATION AND/OR TO CONFIRM THE ALLEGATIONS. NOTE: THE PATIENT MANUAL (PAGE 5) CLEARLY STATES THAT "THE PHYSIO-STIM WILL NOT DELIVER TREATMENT WHILE CHARGING". THE CHARGER DOES NOT CONTACT THE PATIENT DURING TREATMENTS.
Description of Event or Problem · 1
THE PATIENT ALLEGED THAT THE DEVICE CHARGER CAUGHT FIRE AND CAUSED SOME DAMAGE TO THE HOUSE. PATIENT WAS NOT AT HOME (OR WEARING THE DEVICE) AT THE TIME OF INCIDENT. PATIENT REQUESTED ANOTHER STIMULATOR TO CONTINUE TREATMENT. NO FURTHER INFORMATION PROVIDED TO ORTHOFIX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL BONE GROWTH STIMULATOR | 3202 PHYSIO STIM | LOF | ORTHOFIX INC. | 3202 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |