MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN PLUS ULTRA FIT LUBRICATED; CONDOM

Model Number 22600001423

Device Problem Output Problem (3005)

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

Event Date 01/09/2022

Event Type  Injury  

Event Description

The consumer contacted via (b)(6) to allege that although he bought large size trojan plus ultra fit lubricated condoms, he could tell they were too tight.Further, he alleges that while engaging in intercourse, he couldn't feel his penis and that when he pulled out his penis was blue.He additionally alleges that he had to go to the emergency room to have them remove the condom.The consumer did not respond to a request for him to send us a direct message for more information about his experience.In the absence of confirmation and/or medical records to substantiate the experience, this complaint will be reported conservatively based on the reported adverse event.

• Brand Name: TROJAN PLUS ULTRA FIT LUBRICATED
• 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: 13290912
• MDR Text Key: 284109566
• Report Number: 2280705-2022-00001
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00022600001423
• UDI-Public: 00022600001423
• 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: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 22600001423
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2022
• Initial Date FDA Received: 01/19/2022
• 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: Male