MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN BARESKIN CONDOMS 10 CT

Model Number 6170092690

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/14/2021

Event Type  malfunction  

Event Description

The consumer stated that on (b)(6) 2021 she purchased a box of trojan bareskin condoms.She alleges that same evening five of the condoms broke.She further stated that she is on medicaton for (b)(6) which she had disclosed to her partner.He is claiming that she didn't tell him this information and that if she gave him anything that he is coming after her because of this defect.This product would not be expected to be associated with (b)(6); however, in the absence of medical records, we cannot eliminate the potential involvement of the condom.This is being reported conservatively as an (b)(6) is a serious injury.

• Brand Name: TROJAN BARESKIN CONDOMS 10 CT
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• MDR Report Key: 12374770
• MDR Text Key: 283242506
• Report Number: 2280705-2021-00038
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6170092690
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Patient Sequence Number: 1