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

Model Number 2260094732

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/29/2020

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 states that one of the condoms broke and that he was with a partner that may have had genital herpes.We are reporting this as a malfunction with potential exposure to genital herpes and in the absence of additional information from the consumer.

• Brand Name: TROJAN ECSTASY ULTRA RIBBED CONDOMS 10 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: 10787927
• MDR Text Key: 229659671
• Report Number: 2280705-2020-00028
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00022600947325
• UDI-Public: 00022600947325
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120286
• 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: 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: 2260094732
• Device Lot Number: TT0182D
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2020
• 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