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

Model Number	2260095302
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2280705-2022-00012
• Device Sequence Number: 17346812
• Product Code: HIS
• UDI-Device Identifier: 00022600953029
• UDI-Public: 00022600953029
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K912901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 2260095302
• Device Lot Number: TT1143B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female