MAUDE MDR 758555

MDR report key
758555
Report number
MW4004053
Event key
0
Event type
3
Date of event
2005-06-01
Date received
2005-11-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKUNK*KGM***N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-11-080

Event Narratives#

D

Patient 1

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.