MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC TROJAN MAGNUM RAW CONDOMS

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Sexually Transmitted Infection (4555)

Event Type  Injury  

Event Description

This spontaneous report ((b)(4)) from canada was reported by a consumer (age and gender unspecified) who alleged via social media post that the condom was so thin and they got acquired immunodeficiency syndrome (aids).On an unspecified date, the consumer used trojan magnum raw condoms unspecified.The consumer alleged via social media post that the condom was so thin and they got aids.No additional information was available.The action taken with trojan magnum raw condoms unspecified was not applicable.The outcome of the event aids was unknown.The outcome of the event condom was so thin was not applicable.Note: the event can be understood that the reporter could have been infected or infected partner.

• Brand Name: TROJAN MAGNUM RAW CONDOMS
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC; 469 north harrison street; princeton NJ 08543
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 18038965
• MDR Text Key: 326966863
• Report Number: 2280705-2023-01646
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other