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

Model Number	2260064614
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	05/08/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing, nj
• MDR Report Key: 10087806
• Report Number: 2280705-2020-00016
• Device Sequence Number: 19434397
• Product Code: HIS
• UDI-Device Identifier: 00022600646143
• UDI-Public: 00022600646143
• Combination Product (Y/N): N
• PMA/510(K) Number: K895640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2260064614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR