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

Device Problem Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This spontaneous report ((b)(4)) from the united states of america was reported by a consumer (age and gender unspecified) whose condom kept falling off coincident with trojan latex condom unspecified.The consumer's medical history and concomitant medications were not reported.On an unspecified date, the consumer used the trojan latex condom unspecified.The consumer stated that the kept falling off.No additional information was available.The action taken with trojan latex condom unspecified and outcome of the event was not applicable.

• Brand Name: TROJAN LATEX 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: 15637880
• MDR Text Key: 306840482
• Report Number: 2280705-2022-01562
• 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: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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
• 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