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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHURCH & DWIGHT CO., LTD. TROJAN ENZ WITH ARMOR SPERMICIDAL LUBRICANT CONDOMS

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CHURCH & DWIGHT CO., LTD. TROJAN ENZ WITH ARMOR SPERMICIDAL LUBRICANT CONDOMS Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problems Pain (1994); Urinary Tract Infection (2120); Cramp(s) (2193); Reaction (2414)
Event Date 10/19/2018
Event Type  Injury  
Event Description
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.
 
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Brand NameTROJAN ENZ WITH ARMOR SPERMICIDAL LUBRICANT CONDOMS
Type of DeviceCONDOM
Manufacturer (Section D)
CHURCH & DWIGHT CO., LTD.
MDR Report Key8014573
MDR Text Key125630629
Report NumberMW5080897
Device Sequence Number1
Product Code HIS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/26/2018 Patient Sequence Number: 1
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