FDA Adverse Event
Injury
Summary report: N
LIPOZAP
MDR report key: 1861383
·
Received September 8, 2010
Report
- Report Number
- MW5017682
- Event Type
- Injury
- Date Received
- September 8, 2010
- Date of Event
- April 2, 2008
- Report Date
- September 8, 2010
- Manufacturer
- MEDAESTHETICA
- Product Code
- MUU
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SINCE ENDING OF LIPOZAP SERVICES THROUGH MEDAESTHETICA, I HAVE HAD LUMPY SKIN DEFORMATION AND KNOTS ON AREAS THAT WERE TREATED. DAMAGE IS STILL PRESENT TO THIS DAY. DATES OF USE: (B)(6)2007-(B)(6)2008. DIAGNOSIS OR REASON FOR USE: LIPOZAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIPOZAP | LIPOZAP | MUU | MEDAESTHETICA | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Required Intervention |