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

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2019

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 actually occurred.Also, please note that this report is being submitted late due to technical issues with the esg help desk establishing my production account.All emails with the esg help desk regarding this issue have been saved and can be provided if necessary.

Event Description

The consumer stated that he used these condoms all of his life and they break every time.The consumer also stated that he had to get a std test after this happened.He also alleges that a friend of his is currently undergoing a pep treatment because the condom broke.

Event Description

The consumer stated that he used these condoms all of his life and they break everytime.The consumer also stated that he had to get a std test after this happened.He also alleges that a friend of his is currently undergoing a pep treatment because the condom broke.

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 actually occurred.This report has been corrected to remove the statement that was in the initial report in section h10 regarding the report being submitted late due to technical issues.

• Brand Name: TROJAN LATEX CONDOMS UNSPECIFIED
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• MDR Report Key: 9598105
• MDR Text Key: 177582849
• Report Number: 2280705-2020-00003
• 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,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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: 12/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention