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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 Use of Device Problem (1670)
Patient Problems Choking (2464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/01/2021
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
A contact was received via instagram from someone who alleges that he inhaled a condom during oral sex and choked. He also alleges that he sought medical attention in the er and had surgery. The consumer did not respond to a follow-up request to obtain more information about his experience. This product was not used as per label, as it is not meant to be inhaled. The reported experience cannot be confirmed, nor can the product be eliminated as a potential contributory factor for the reported symptoms. In the absence of confirmation, this contact will be reported conservatively, as this can be a serious injury.
 
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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 Key12516323
MDR Text Key272868832
Report Number2280705-2021-00041
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 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
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 Received09/01/2021
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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