MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN LATEX ECSTASY CONDOMS UNSPECIFIED

Device Problem Break (1069)

Patient Problem Viral Infection (2248)

Event Type  Injury  

Manufacturer Narrative

As per reviewer, the consumer experience did not involve a death or represent potential serious harm to public health.The consumer did not indicate seeking medical treatment.The consumer did present the following symptoms listed in chd-sop-1330 as indicative of potential serious injury :["now have an std"].A lot code search could not be generated for quality review; consumer did not provide a lot code.

Event Description

This spontaneous report (2022-cdw-00146, (b)(6)) from the (b)(6) was reported by a consumer and concerns a male patient (age unspecified) who experienced a sexually transmitted disease (std) and i had a one night stand, wore a condom i now have an std and i am going to be a father coincident with trojan latex ecstasy condoms unspecified.The patient's medical history and concomitant medications were unknown.On an unspecified date, the patient initiated trojan latex ecstasy condoms unspecified for unknown indication.The patient had a one night stand, wore a condom and had a std.The patient also mentioned that he is going to be a father.No additional information was available.As per the reportability review, the consumer experience did not involve a death or represent potential serious harm to public health.The consumer did not indicate seeking medical treatment.The consumer did present the following symptoms listed in chd-sop-1330 as indicative of potential serious injury :["now have an std"].A lot code search could not be generated for quality review; consumer did not provide a lot code.Action taken with trojan latex ecstasy condoms unspecified was not applicable.The outcome of the i now have a std was unknown.The outcome of the i had a one night stand, wore a condom i now have a std and i am going to be a father was not applicable.

• Brand Name: TROJAN LATEX ECSTASY CONDOMS UNSPECIFIED
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 469 north harrison street; princeton NJ 08540
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08540
• MDR Report Key: 14490884
• MDR Text Key: 293351897
• Report Number: 2280705-2022-00146
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2022

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2022
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male