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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2024

Event Type  malfunction  

Event Description

The fda regulates condoms as class ii devices.My understand is that condoms are tested by the manufacturer and/or the fda.However, the conditions of the testing usually occur above freezing temperatures (0 degrees celsius).This is different from their use in practice, which sometimes involves exposure to freezing temperatures.If there is any amount of water in or on the condom, the water would form crystals that would weaken the condom, even after a brief excursion below freezing temperature.To test this, i placed an unopened condom in a freezer for 5 minutes and confirmed that the condom was weakened in that the freezing changed how the condom stretches.A study of condom breakage found that progressive stretching of condoms precede breakage.(white, nicholas d., david m.Hill, and steffen bodemeier."male condoms that break in use do so mostly by a "blunt puncture" mechanism." contraception 77.5 (2008): 360-365.) therefore, (1) please require that condom manufacturer testing be repeated before and after exposure to freezing temperatures as part of routine sampling; (2) include a warning label on the condom packaging regarding brief excursions to freezing temperatures, if appropriate; (3) ensure that delivery companies who drive to the home to deliver condoms do so without excursions to extreme temperatures.

• Brand Name: TROJAN ENZ CONDOMS
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.
• MDR Report Key: 18486980
• MDR Text Key: 332784558
• Report Number: MW5150097
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other