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

Model Number	22600001423
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/09/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• 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: 13290912
• Report Number: 2280705-2022-00001
• Device Sequence Number: 4547619
• Product Code: HIS
• UDI-Device Identifier: 00022600001423
• UDI-Public: 00022600001423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120286
• 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): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 22600001423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2022
• Initial Report FDA Received Date: 01/19/2022
• 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: Male