FDA.reportPublic FDA data

MAUDE MDR 8014573

MDR report key
8014573
Report number
MW5080897
Event key
0
Event type
3
Date of event
2018-10-19
Date received
2018-10-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1TROJAN ENZ WITH ARMOR SPERMICIDAL LUBRICANT CONDOMSCONDOMCHURCH & DWIGHT CO., LTD.HISI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-2601. H

Event Narratives#

D

Patient 1

MY BOYFRIEND AND I HAVE USED THE TROJAN ENZ BRAND CONDOMS FOR A LONG TIME. RECENTLY THEY RELEASED AN ENZ BRAND WITH SPERMICIDAL LUBRICANT (ARMOR SPERMICIDAL LUBRICANT). WITHIN 12 HOURS OF HAVING SEX THE FIRST TIME WE USED THESE, I DEVELOPED EXTREMELY BAD PELVIC PAIN AND LATER SYMPTOMS OF A UTI. I WENT TO THE DR AND SURE ENOUGH, I HAD A UTI. THIS WAS AN ESPECIALLY BAD CASE WITH TERRIBLE PELVIC CRAMPING AND TENDERNESS IN THE PELVIS AND BLADDER. MY DR INFORMED ME THAT SOME WOMEN HAVE THIS REACTION TO SPERMICIDAL LUBRICANTS. IS THE PRODUCT OVER-THE-COUNTER? YES. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT AGAIN? NO. QUANTITY: 1 APPLICATION; HOW WAS IT TAKEN OR USED: TOPICAL; DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2018, DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2018. REASON FOR USE: PREGNANCY PREVENTION.