FDA.reportPublic FDA data

MAUDE MDR 5996447

MDR report key
5996447
Report number
MW5065159
Event key
0
Event type
3
Date of event
2016-09-16
Date received
2016-10-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
999
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
1UNIQUE PULL CONDOMSCONDOMSUNKHIS* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-010

Event Narratives#

D

Patient 1

GOT SOME UNIQUE PULL CONDOMS FROM (B)(4) AND AFTER USING THEM, NOTICED A REDNESS AND SWELLING. PROBLEMS WENT AWAY AFTER ABOUT AN HOUR AND HAVING WASHED THE AREA THOROUGHLY. AFTER THIS INCIDENT, I WENT ONLINE TO INVESTIGATE THE BRAND AND DISCOVERED THAT IT ISN'T FDA APPROVED FOR SALE IN THE US. IN FACT, I FOUND OUT THAT (B)(4) ACTUALLY SELLS A NUMBER OF NON-FDA APPROVED CONDOMS. IS THIS LEGAL? ISN'T THERE A FEDERAL LAW REGARDING THE SALE OF NON-FDA APPROVED TERMS TO THE PUBLIC? PLEASE INVESTIGATE THIS COMPANY. WHILE IT MAY SEEM LIKE A MINOR THING, CONDOMS BY DESIGN INTERACT WITH THE HUMAN BODY IN A VERY INTIMATE WAY. ISSUES OF SAFETY REGARDING THESE ITEMS SHOULD BE HIGH. IF I HAD KNOWN THIS CONDOMS WEREN'T FDA APPROVED! I CERTAINLY WOULDN'T PURCHASED THESE NOR USED THEM.