FDA.reportPublic FDA data

MAUDE MDR 312959

MDR report key
312959
Report number
MW4002926
Event key
0
Event type
3
Date of event
2000-09-14
Date received
2001-01-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REJUVASILK 200MICRODERMABRASION SYSTEMMEDICAL ALLIANCE, INC.GFE**1742N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-01-120

Event Narratives#

D

Patient 1

THE CONSUMER GOT A FLIER IN THE MAIL FOR MICRODERMABRASION FROM A DERMATOLOGIST, AND DECIDED TO HAVE SLIGHTLY SUN-DAMAGED SKIN TREATED. HAD ONE TREATMENT AND ABOUT 1-1/2 WEEKS LATER NOTED THAT THEY HAD HAIR STUBBLE ALL OVER FACE AS IF THEY HAD SHAVED THEIR FACE. WENT BACK TO THE DERMATOLOGIST, WHO TOLD THEM THEY HAD A HORMONE PROBLEM. WENT TO ANOTHER DERMATOLOGIST WHO HAS BEEN DOING ELECTROLYSIS TO REMOVE THE HAIRS, BUT THEY ARE TOO NUMEROUS AND COARSE, ESPECIALLY ON NOSE AND UNDER CHIN. THE SECOND DERMATOLOGIST AND THE CONSUMER'S GYNECOLOGIST DID NOT THINK THEY HAD A HORMONE PROBLEM, AND BELIEVED HAIR FOLLICLES WERE DAMAGED DURING THE MICRODERMABRASION. TRAUMA TO HAIR FOLLICLES CAUSED COARSE HAIR GROWTH ON FACE; COMPLAINANT FILED A COMPLAINT AGAINST THE DERMATOLOGIST.