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

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.

• 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 Key: 12516323
• MDR Text Key: 272868832
• Report Number: 2280705-2021-00041
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 15 YR