MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN PLEASURE PACK CONDOMS 12 CT

Model Number 2260095302

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2022

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 here in or that the event as reported to church & dwight actually occurred.

Event Description

The consumer claims to be an escort and alleges that the trojan condom broke.She states that she now has to find a clinic.This event is reportable based on the allegation of a product malfunction, with the potential exposure to an std.

• Brand Name: TROJAN PLEASURE PACK CONDOMS 12 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 drive; south chesterfield VA 23834
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 13942494
• MDR Text Key: 298226271
• Report Number: 2280705-2022-00012
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00022600953029
• UDI-Public: 00022600953029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912901
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2260095302
• Device Lot Number: TT1143B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 03/29/2022
• 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 Sex: Female