UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-08 for UNK * manufactured by *.

Event Text Entries

[540712] Complainant states that practitioner does not have a cosmetologist's license and owns a massage and facial parlor. Inside the shop, wrinkle injections occur, with substance 'from animal fat' and claims that it is fda approved. About 7-8 yrs ago, the complainant had an injection into chin, and now felt some pain in her chin. She went to go see her doctor, approx 4 months ago, in another country, who told her that the injection was made of silicone, which wasn't supposed to be injected. The silicone was removed. The complainant's family member also had injections done in her upper eyebrows, and now says that it is harder to open her eyes. They went to go see a cosmetic doctor. The complainant said she has a sample of the silicone removed from family member's eye, as well as a doctor's letter identifying it as such. Surgery was done to remove the item. The complainant and the sister went to massage and facial parlor regarding the matter, and they denied the claims. The complainant asked for payment of medical claims and compensation. According to the complainant, they said that if they said that it was silicone, no one would get the procedures done. The complainant spent $15,000. They accept only cash, and only have a massage license. A complaints dept for licensing matters, a consumer complaints dept noted that there were 5 women who complained about it. The fbi, according to the complainant, has been informed. In the middle of october, the complainant alleges that massage parlor fled.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4004053
MDR Report Key758555
Date Received2005-11-08
Date of Report2005-11-01
Date of Event2005-06-01
Date Added to Maude2006-09-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameUNK
Product CodeKGM
Date Received2005-11-08
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key746476
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2005-11-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.