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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN BARESKIN CONDOMS 3 CT
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CHURCH & DWIGHT CO., INC. TROJAN BARESKIN CONDOMS 3 CT Back to Search Results
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 12/07/2020
Event Type  malfunction  
Event Description
The consumer states that he purchased a box of trojan bareskin condoms and they allegedly broke every time.He further stated that he wears condoms to protect himself as his partner has (b)(6).In the absence of confirmation, this is reportable based on the allegation of product malfunction.
 
Manufacturer Narrative
This report and the information submitted under this report do not constitute an admission that the device or church & dwight co., inc.Or any of its employees caused or contributed to the event described herein or that the event as reported to church & dwight co., inc.Actually occurred.
 
Event Description
The consumer states that he purchased a box of trojan bareskin condoms and they allegedly broke every time.He further stated that he wears condoms to protect himself as his partner has hepatitis c.In the absence of confirmation, this is reportable based on the allegation of product malfunction.
 
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Brand Name
TROJAN BARESKIN CONDOMS 3 CT
Type of Device
CONDOM
Manufacturer (Section D)
CHURCH & DWIGHT CO., INC.
500 charles ewing boulevard
ewing NJ 08628
MDR Report Key11028940
MDR Text Key222684386
Report Number2280705-2020-00034
Device Sequence Number1
Product Code HIS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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