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

Model Number 2260064614

Device Problems Break (1069); Product Quality Problem (1506)

Patient Problem Urinary Tract Infection (2120)

Event Date 05/08/2020

Event Type  Injury  

Event Description

The consumer alleges that all three condoms in the box broke.The condoms broke near the tip and around the circumference during intercourse.He began using the condoms from this particular box on (b)(6) 2020 and finished using all of the condoms on (b)(6) 2020.He also believes that he contracted a urinary tract infection from these condoms.He further explained that starting on (b)(6) 2020, he experienced burning with urination.As of (b)(6) 2020 (when he contacted us), he is still experiencing these symptoms.He did not seek medical attention.

• Brand Name: TROJAN MAGNUM THIN CONDOMS
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing, nj
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC.; 1851 touchstone drive; south chesterfield, va
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, nj ; 8067868
• MDR Report Key: 10087806
• MDR Text Key: 192021387
• Report Number: 2280705-2020-00016
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00022600646143
• UDI-Public: 00022600646143
• Combination Product (y/n): N
• PMA/PMN Number: K895640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2260064614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• 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
• Patient Age: 40 YR