MAUDE MDR 2501037

MDR report key
2501037
Report number
MW5024712
Event key
0
Event type
3
Date of event
2012-03-05
Date received
2012-03-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
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
1KOTEX U NIGHT TIME PADSPADHHDKOTEX U ALLNIGHTER Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-2001. R

Event Narratives#

D

Patient 1

DOCUMENT (B)(4). IT STARTED WHEN I BOUGHT KOTEX U NIGHT TIME PADS. I USED IT FOR THE FIRST TIME ON SATURDAY NIGHT AND BY MONDAY I NOTICED A LARGE BUMP ON MY LEFT BUTTOCKS, BY TUESDAY MORNING, I HAD A SEVERE RASH THE EXACT SAME SIZE AND SHAPE AS THE PAD. I WENT TO THE DR WHO HAD TO PUT ME ON 2 DIFFERENT ANTIBIOTICS DUE TO RISK OF STAPH INFECTION. BY WEDNESDAY, MY RASH HAS SWOLLEN 3 TIMES THE SIZE AND STARTED SEEPING. MY DR SENT ME STRAIGHT TO ER WHERE THEY INJECTED ME WITH A STEROID AND SENT ME HOME ON 2 DIFFERENT STEROIDS. THEY TOLD ME NOT TO RETURN TO WORK UNTIL MONDAY DUE TO SIGNIFICANT INFECTION, I CALLED KOTEX/KIMBERLY CLARK AND SPOKE TO (B)(4) WHO ASSURED ME THAT SHE'S NEVER HEARD OF THIS; HOWEVER, WHEN I INVESTIGATED I FOUND THAT ON KOTEX'S OWN WEB SITE (WWW.COMMUNITY.KOTEX.COM) THAT THERE ARE MANY PEOPLE WITH SIMILAR HORROR STORIES. NOW I HAVE TO GO SEE A DERMATOLOGIST TOMORROW. AFTER 2 DRS APPOINTMENTS, AND ER VISIT, OVER (B)(6) IN MEDICATION AND 2 DAYS OFF WORK WITHOUT PAY I AM FURIOUS, IN EXTREME PAIN, EMBARRASSED AND HIGHLY DISAPPOINTED FROM A FEMININE PRODUCT THAT NOT ONLY DOESN'T LIST THE INGREDIENTS OF THEIR PRODUCT, BUT APPALLED THAT FEMININE PRODUCT DO NOT HAVE TO LABEL THEMSELVES AS HYPO ALLERGENIC OR NON-HYPO ALLERGENIC. AND FYI- I'VE NEVER HAD ANY ALLERGIES OR SENSITIVITIES PRIOR TO THIS SO WHATEVER KOTEX IS USING (MADE IN (B)(6)) IS OBVIOUSLY NOT SAFE FOR ALL WOMEN. RETAILER: (B)(6). PURCHASE DATE: (B)(6) 2012. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. REPORT#: (B)(4).