• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN LATEX CONDOM UNSPECIFIED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 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
0 Patients were Involved in the Event:
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2021
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 Unkown

-
-