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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 Break (1069)
Patient Problem Sexually Transmitted Infection (4555)
Event Date 03/26/2022
Event Type  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 actually occurred.
 
Event Description
A contact was received from a consumer via facebook stating that he has tried numerous styles of condoms and always had at least one break while in use.Allegedly, he had to take medication due to contracting chlamydia and the female partner had to use plan b pills.We do not have medical records to substantiate this experience.
 
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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 Key14047408
MDR Text Key298226369
Report Number2280705-2022-00014
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 Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received03/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
Patient SexMale
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