MAUDE MDR 3805750

MDR report key
3805750
Report number
MW5036007
Event key
0
Event type
3
Date of event
2014-02-11
Date received
2014-05-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALWAYS MAXI SOFT AND CLEAN ODOR LOCKALWAYS MAXI SOFT AND CLEAN ODOR LOCKPROCTOR AND GAMBLEHHD4009478600 42

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-05-0601. O; 2. S

Event Narratives#

D

Patient 1

ON (B)(6) 2014, I BOUGHT ALWAYS PADS FROM (B)(4). I PUT ONE ON AT SCHOOL. ABOUT AN HOUR INTO MY CLASS I FELT SOME IRRITATION ON MY BOTTOM. WITHIN A FEW DAYS, I BROKE OUT WITH FULL BLOWN BLISTERS FROM THE FRONT OF MY VAGINA TO THE BACK OF MY BOTTOM. THE BLISTERS WERE IN THE EXACT PATTERN OF THE PAD. THEY WERE SO PAINFUL I COULD BARELY SLEEP, WALK OR TAKE A SHOWER. I TOOK PICTURES OF THE SCARS THEY LEFT. THEY WERE SO PAINFUL. I COULDN'T CARE FOR MY 3 CHILDREN, SIT DURING MY CLASSES, OR DO HOUSEHOLD CHORES. MY DR. THINKS I GOT 3RD DEGREE CHEMICAL BURNS FROM THE CHEMICAL IN THE PAD. SHE GAVE ME ALOE VERA WITH LIDOCAINE AND SILVER SULFADIAZINE CREAM TO EASE THE PAIN. THIS LASTED FOR MORE THAN A MONTH. NOW THAT IM HEALED, THE LEFT SIDE OF MY VAGINA, AND INSIDE MY ANUS WHERE THE CHEMICAL HAD GOTTEN IS COMPLETELY NUMB. I HAVE NO FEELING LEFT AT ALL FROM THE CHEMICAL BURNS. I HAVE THE PACKAGE OF PADS. I HAVE THE RECEIPTS, I HAVE PICTURES, MY TEST RESULTS AND A JOURNAL. THIS HAPPENED OVER VALENTINES DAY WEEKEND AND DESTROYED THE ENTIRE MONTH OF (B)(4). PLEASE CALL OR EMAIL IF YOU HAVE ANY FURTHER QUESTIONS. I WOULD HATE FOR THIS TO HAPPEN TO SOMEONE ELSE OR FOR A CHILD TO GET A HOLD OF THESE. DIAGNOSIS OR REASON FOR USE: USED DURING PERIOD.