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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN LATEX CONDOM UNSPECIFIED
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CHURCH & DWIGHT CO., INC. TROJAN LATEX CONDOM UNSPECIFIED Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Sexually Transmitted Infection (4555)
Event Date 07/04/2021
Event Type  Injury  
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 alleges that she contracted a sexually transmitted disease from these condoms.While there was no indication of a product malfunction (breakage), in the absence of confirmation, this complaint will be conservatively reported based on the allegation of contracting an std.Of note, there is nothing in a condom to cause an std.Additionally, she alleges that her boyfriend got bumps on his penis.Lastly, she alleges that her child tried eating the condom and almost died.A lot code search could not be generated for incident review as the consumer did not provide a lot code.
 
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Brand Name
TROJAN LATEX CONDOM UNSPECIFIED
Type of Device
CONDOM
Manufacturer (Section D)
CHURCH & DWIGHT CO., INC.
500 charles ewing boulevard
ewing NJ 08628
Manufacturer Contact
stacey harshaw
469 north harrison street
princeton, NJ 08543
6098067868
MDR Report Key12174711
MDR Text Key261907474
Report Number2280705-2021-00033
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
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/04/2021
Initial Date FDA Received07/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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