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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 Material Split, Cut or Torn (4008)
Patient Problem HIV, Human Immunodeficiency Virus (2197)
Event Date 01/16/2021
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 co. , inc. Actually occurred. Additional information: the consumer did not respond to follow-up requests, so we were unable to obtain the medical device for further examination.
 
Event Description
The consumer alleges that the condoms ripped while engaging in intercourse. The consumer also alleges contracting aids. In the absence of confirmation, this complaint is being reported based on the allegation of a product malfunction, with the allegation of contracting an std.
 
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Brand NameTROJAN LATEX CONDOM UNSPECIFIED
Type of DeviceCONDOM
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 Key11240414
MDR Text Key230040099
Report Number2280705-2021-00004
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 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2021
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?
Type of Device Usage Unkown

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