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

Model Number 2260099853

Device Problem Material Puncture/Hole (1504)

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

Event Date 10/13/2020

Event Type  malfunction  

Event Description

The consumer states that he purchased a 24 pack of trojan bareskin condoms.He alleges that out of the first five condoms, three ripped.He further stated that he has (b)(6).This is being reported as a malfunction with a risk of exposure to a sti.

• Brand Name: TROJAN BARESKIN CONDOMS
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer (Section G): OKAMOTO INDUSTRIES, INC.; no. 1, nishiyama-itabashi-cho; ryugasaki-shi, ibaraki-prefecture 301-0 801; JA 301-0801
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 10722165
• MDR Text Key: 214119860
• Report Number: 2280705-2020-00027
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00022600998532
• UDI-Public: 00022600998532
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090259
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2260099853
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/13/2020
• 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: Unknown
• Patient Sequence Number: 1