FDA Adverse Event
Malfunction
Summary report: N
TEAR TECH 2000
MDR report key: 508841
·
Received January 9, 2004
Report
- Report Number
- 2085494-2003-00010
- Event Type
- Malfunction
- Date Received
- January 9, 2004
- Date of Event
- December 7, 2003
- Report Date
- December 23, 2003
- Manufacturer
- VISION QUEST INDUSTRIES, INC.
- Product Code
- IPF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT CALLED IN 12/2003 STATING THAT THE UNIT SPARKED ELECTRICITY. (ORANGE AND YELLOW) AT THE TIME OF THE STANDARD ELECTRODES 4 TIMES A DAY. IT WAS SET ON PRE-SET 1, AT AN INTENSITY LEVEL OF 28 AMPS. PATIENT WAS LYING DOWN, AND THE BEGAN TO FEEL A SHOCK. PATIENT STOOD UP AND LOOKED IN THE MIRROR AND SAW A BRIGHT LIGHT. DURING THIS PATIENT FELT A SHOCK THAT WAS "PINCHING" AND "BURNING" PATIENT. PATIENT HAS NEVER DROPPED THE UNIT AND HAS TAKEN CARE OF IT. PATIENT ALSO HAD RECEIVED A PEN MARK OR PIMPLE THAT WAS SCABBING, PATIENT FELT THAT THE MARK WAS PERMANENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEAR TECH 2000 | MUSCLE STIMULATOR | IPF | VISION QUEST INDUSTRIES, INC. | SA32-7A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |