FDA Adverse Event
Injury
Summary report: N
LIPO LAX
MDR report key: 13152998
·
Received January 3, 2022
Report
- Report Number
- MW5106442
- Event Type
- Injury
- Date Received
- January 3, 2022
- Date of Event
- December 8, 2021
- Report Date
- December 25, 2021
- Manufacturer
- UNK
- Product Code
- LMH
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
BOUGHT BOTOX FROM (B)(6) IN THE USA AND FILLER FOR MY FACE. THE BOTOX MADE ME BREAK INTO HIVES, CAUSED BLINDNESS AND THE FILLER WAS RUNNY. THE BOTOX AND FILLER ARE BAD, NOT TRUE BOTOX AND SILICONE LIKE FILLER. ALL BOUGHT IN THE USA (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 792158 | LIPO LAX | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | UNK | |||
| 792159 | BOTOX | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | UNK | |||
| 792160 | DERMAL FILLER | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Hospitalization |