MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN LATEX CONDOM UNSPECIFIED

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

The consumer contacted via (b)(6) and stated that he used a condom that broke mid way through and alleges that he now has (b)(6).In the absence of medical records to substantiate the claim, this contact will be reported conservatively.

• Brand Name: TROJAN LATEX CONDOM UNSPECIFIED
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 12790254
• MDR Text Key: 284871755
• Report Number: 2280705-2021-00053
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male