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

Device Problem Break (1069)

Patient Problems Pregnancy with a Contraceptive Device (4517); Sexually Transmitted Infection (4555)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

A contact was received via (b)(6) from someone who alleges that the condom broke and gave him (b)(6).He also alleges having a child now as a result of the condom breakage.The consumer did not respond to a follow-up request to obtain more information about the experience.

• Brand Name: TROJAN LATEX CONDOM UNSPECIFIED
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• MDR Report Key: 12632789
• MDR Text Key: 281407173
• Report Number: 2280705-2021-00045
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1