MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN MAGNUM BARESKIN CONDOMS

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2021

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.

Event Description

The consumer stated that her boyfriend has herpes.They purchased these condoms to protect her during intercourse.She alleges that two out of five condoms broke during intercourse.She is now concerned about the possibility of having contracted herpes.This is being reported based on the allegation of a product malfunction with the allegation of possibly contracting an std.

• Brand Name: TROJAN MAGNUM BARESKIN CONDOMS
• 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: 11516007
• MDR Text Key: 243099902
• Report Number: 2280705-2021-00007
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1