MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN MAGNUM XL CONDOMS UNSPECIFIED; CONDOM, PRODUCT CODE: HIS

Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bacterial Infection (1735); Skin Discoloration (2074)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The consumer reports that the condoms keep breaking every time he has sex.Additionally, when he would take the condom off, his penis appeared purple.He sought medical attention from an urgent care center.After having an std test, he was diagnosed with (b)(6).The consumer reported he is fine now and was cleared of (b)(6).

• Brand Name: TROJAN MAGNUM XL CONDOMS UNSPECIFIED
• Common Device Name: CONDOM, PRODUCT CODE: HIS
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• MDR Report Key: 8906377
• Report Number: 2280705-2019-00017
• Device Sequence Number: 18088837
• Product Code: HIS
• Combination Product (Y/N): N
• 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): 07/16/2019

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?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR