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

Device Problem Break (1069)

Patient Problem Immunodeficiency (2156)

Event Type  Injury  

Event Description

This spontaneous report (2022-cdw-01026, 007581225a) from the united states of america was reported by a consumer (age and gender unspecified) whose one of the condoms broke and developed acquired immunodeficiency syndrome (aids) coincident with trojan latex lubricated condom unspecified.The consumer's medical history and concomitant medications were not reported.On an unspecified date, the consumer initiated trojan latex lubricated condom unspecified (lot number: unknown).The consumer stated that one of the condoms got broke, and the consumer developed aids.Later, the consumer switched to durex.No additional information was available.The action taken with trojan latex lubricated condom unspecified was withdrawn.The outcome of the event aids was unknown.The outcome of the event one of the condoms broke was not applicable.

• Brand Name: TROJAN LATEX LUBRICATED CONDOM 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 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 15273831
• MDR Text Key: 298387059
• Report Number: 2280705-2022-01026
• 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: 07/18/2022

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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