FDA Adverse Event
Summary report: N
AB ENERGIZER
MDR report key: 438045
·
Received January 15, 2003
Report
- Report Number
- MW1027280
- Date Received
- January 15, 2003
- Date of Event
- June 1, 2002
- Report Date
- January 15, 2003
- Manufacturer
- UNK
- Product Code
- IPF
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IN 2002, PT. USED THE "AB ENERGIZER BELT", WITH GEL, AND SUSTAINED A BURN TO THEIR ABDOMEN. ONE WEEK AFTER INITIAL INCIDENT, CONSUMER USED THE BELT, WITHOUT THE GEL, SUSTAINED A BURN TO ABDOMEN. THEY DID NOT SEEK MEDICAL TREATMENT. THEY SELF TREATED WITH "CREAMS THEY HAD IN THE HOUSE." PT'S GODCHILD ALSO USED THE BELT AND ALSO SUSTAINED A BURN. CONSUMER STATED THEY PURCHASED DEVICE AFTER SEEING PRODUCT ADVERTISED ON TELEVISION FOR THE PURPOSE OF WEIGHT LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AB ENERGIZER | ABDOMINAL BELT FOR WEIGHT LOSS | IPF | UNK | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |