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

Model Number	2260064614
Health Effect - Clinical Code	Sexually Transmitted Infection (4555)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
An (b)(6) review was received from someone alleging that he has aids and has only one year left to live after a sexual encounter with a woman he met.There is no actual indication of a product malfunction or that the product was even used although it is implied.In the absence of confirmation, this event is reportable based on the allegation of contracting an std/sti.

• Brand Name: TROJAN MAGNUM THIN 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: 12961791
• Report Number: 2280705-2021-00056
• Device Sequence Number: 6046354
• Product Code: HIS
• UDI-Device Identifier: 00022600646143
• UDI-Public: 00022600646143
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K895640
• 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): 12/08/2021

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: 2260064614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/08/2021
• 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: Male