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

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Skin Irritation (2076); Wheal(s) (2241); Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2019

Event Type  malfunction  

Event Description

The consumer states that the condom ripped.He also states that everything stayed inside of his female partner when he took it out.He also stated that it hurt and he had blisters from the heat.This is being reported as a malfunction with a potential for serious injury.

• Brand Name: TROJAN FIRE & ICE CONDOMS UNSPECIFIED
• Type of Device: LATEX CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing blvd.; ewing NJ 08628
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC.; 1851 touchstone drive; south chesterfield VA 23834
• Manufacturer Contact: stacey harshaw ; 469 north harrison st.; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 9349742
• MDR Text Key: 197318692
• Report Number: 2280705-2019-00031
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120287
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1