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

Model Number 2260064614

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sexually Transmitted Infection (4555)

Event Date 11/22/2021

Event Type  malfunction  

Event 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
• 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: 12961791
• MDR Text Key: 283483084
• Report Number: 2280705-2021-00056
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00022600646143
• UDI-Public: 00022600646143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895640
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2260064614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2021
• 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: Male