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

Device Problem Break (1069)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

This spontaneous report (2023-cdw-00747, 007756135a) from the united states of america was reported by a consumer (age and gender unspecified) whose condom broke and got exposed to human immunodeficiency virus (hiv) while using trojan magnum xl condoms unspecified.The consumer's medical history and concomitant medication were not reported.On (b)(6) 2023, the consumer used the trojan magnum xl condoms unspecified, used one.The consumer stated that the condom broke while using it.The consumer got exposed to hiv, as the consumer's partner had it.No additional information was available.The action taken with trojan magnum xl condoms unspecified and the events were not applicable.

• Brand Name: TROJAN MAGNUM XL CONDOMS UNSPECIFIED
• 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 08268
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 16851339
• MDR Text Key: 314455960
• Report Number: 2280705-2023-00747
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2023

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other