MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN FIRE & ICE CONDOMS 3 CT

Model Number 2260096003

Device Problem Break (1069)

Patient Problem Herpes (1898)

Event Date 10/20/2020

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 he put on two condoms at one time and had intercourse.The outer condom tore at the top.He further stated that the next day it burned when he urinated.The consumer went to the emergency room where he alleges that he tested positive for genital herpes.In the emergency room, they recommended an over the counter cream at (b)(4).He still has ongoing symptoms.We don't have medical records to confirm this diagnosis.Also, there was no mention of the second condom breaking; however, we don't have additional records to confirm this information.

• Brand Name: TROJAN FIRE & ICE CONDOMS 3 CT
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC.; 1851 touchstone road; south chesterfield VA 23834
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 10788574
• MDR Text Key: 229812856
• Report Number: 2280705-2020-00029
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00022600960034
• UDI-Public: 00022600960034
• Combination Product (y/n): N
• PMA/PMN Number: K120287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2260096003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• 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: 19 YR