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

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2021

Event Type  malfunction  

Event Description

The consumer contacted via (b)(6) to state that his trojan condom broke last night (based on date of contact, the breakage would have occurred on (b)(6) 2021).He stated: thanks trojan brand condoms now i probably have aids.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
• MDR Report Key: 12478055
• MDR Text Key: 280538827
• Report Number: 2280705-2021-00040
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/15/2021

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1