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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 Viral Infection (2248)
Event Date 10/05/2021
Event Type  malfunction  
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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 Key12632438
Report Number2280705-2021-00044
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 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
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 Received10/05/2021
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

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