MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN BARESKIN CONDOMS, PREMIUM LUBRICANT; CONDOM

Lot Number CZ 9234H5

Device Problem Device Emits Odor (1425)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

Very bad smell; this has happened very many times over 2021.I only recently connected the dots.Trojan bareskin condoms with premium lubricant have a bitter smell, and after using them, i can smell it in my arm pits the next day.It seems to be absorbed into our bodies during use and then ends up in our lymphatic system.

• Brand Name: TROJAN BARESKIN CONDOMS, PREMIUM LUBRICANT
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.
• MDR Report Key: 12540010
• MDR Text Key: 273774846
• Report Number: MW5104220
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: CZ 9234H5
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 63