FDA Adverse Event
Injury
Summary report: N
VECTRA GENISYS 2CH COMBO PKG
MDR report key: 3062920
·
Received April 12, 2013
Report
- Report Number
- 9616086-2013-00003
- Event Type
- Injury
- Date Received
- April 12, 2013
- Date of Event
- March 8, 2013
- Report Date
- April 12, 2013
- Manufacturer
- DJO, LLC
- Product Code
- IMG
- PMA / PMN Number
- K031077
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT WAS BURNED AND TREATMENT WAS INTERRUPTED WHEN USING E-STIM ON INTERFERENTIAL. PATIENT SUFFERED 2ND DEGREE BURN UNDER ELECTRODES AND WAS TREATED BY WOUND CARE SPECIALIST USING A COLD COMPRESS AND ICE THE FIRST DAY AND SILVADENE BURN CREAM THEREAFTER. DEVICE IFU STATES BURN AS A POTENTIAL ADVERSE EFFECT WITH USE OF ELECTRODES. DEVICE IFU INCLUDES WARNING THAT DEVICE SHOULD ONLY BE USED WITH THE ELECTRODES RECOMMENDED FOR USE BY THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157774 | VECTRA GENISYS 2CH COMBO PKG | ELECTROTHERAPY - CLINIC | IMG | DJO, LLC | 2761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |