FDA.reportPublic FDA data

MAUDE MDR 9877588

MDR report key
9877588
Report number
2184163-2020-00001
Event key
0
Event type
3
Date of event
2019-12-31
Date received
2020-03-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. EMILY ARNOULD, RN BSN
Address
2100 WINCHESTER RD NEENAH WI 54956 US
Phone
920-920-9207
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQGARMENT, PROTECTIVE, FOR INCONTINENCENEENAH COLD SPRING FACILITYEYQFIT FLEX UNDERWEAR FOR WOMEN, LARGE, MAXIMUM ABSORLF925918X2222N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2501. H; 2. O

Event Narratives#

N

Patient 1

REVIEW OF THE DEVICE HISTORY RECORD (DHR), SUPPORTING QUALITY RECORDS, AND TWO COMPANION SAMPLES CONFIRMED NO ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

D

Patient 1

CONSUMER REPORTED A HALF HOUR INTO WEARING A DEPEND FIT FLEX UNDERWEAR FOR WOMEN SHE BEGAN TO EXPERIENCE A REACTION WITH DISCOMFORT, REDNESS, SWELLING, VAGINAL ODOR AND PAIN. SHE ALLEGED HER ARMS, WRISTS, HANDS AND VAGINA WERE SWOLLEN AND ITCHY. SHE WENT TO THE HOSPITAL VIA AMBULANCE. DURING TRANSPORT SHE WAS GIVEN IV BENADRYL BY EMS. IN THE EMERGENCY ROOM (ER) SHE WAS DIAGNOSED WITH ACUTE CONTACT DERMATITIS AND GIVEN CEFTRIAXONE IV AND ALSO PREDNISONE AND FAMOTIDINE. SHE WAS HOSPITALIZED FOR OBSERVATION FOR TWO NIGHTS AND DISCHARGED HOME WITH TAPERING DAILY ORAL STEROIDS AND DAILY FAMOTIDINE. CONSUMER REPORTED SHE WAS FEELING MUCH BETTER AND HAD RECOVERED FROM HER REACTION.