MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN LATEX EXTENDED PLEASURE LUBRICATED CONDOMS

Model Number	2260001996
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Viral Infection (2248)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As per review, though the complaint alleged malfunction of a medical device, it did not involve any of the following: battery explosion, fire/flame/smoke, spinbrush product breakage (involving the generation of small parts excluding bristles), condom breakage associated with sti exposure, condom breakage with location "cdcan", corrosive liquid, or other unusual malfunction.Not a malfunction with the potential to cause a serious injury.A lot code search was generated for quality review; no similar quality complaints for this product and lot code combination were reported.
Event or Problem Description
This spontaneous report (2022-cdw-00144, 007528235a) from the united states of america was reported by a consumer and concerns a patient (age and gender unspecified) who was diagnosed with aids as coincidently condom ripped ((b)(6) condoms).The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient initiated (b)(6) condoms for unknown indication.The patient stated condom ripped and patient was diagnosed with aids (acquired immunodeficiency syndrome).No product sample for pleasure lubricated condoms received.No additional information was available.Action taken with (b)(6) condoms not applicable.The outcome of the event i just got diagnosed with aids was unknown.The outcome of the event condom ripped was not applicable.

• Brand Name: TROJAN LATEX EXTENDED PLEASURE LUBRICATED CONDOMS
• Common Device Name: CONDOMS
• 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: 14487004
• Report Number: 2280705-2022-00144
• Device Sequence Number: 12096439
• Product Code: HIS
• UDI-Device Identifier: 00022600999393
• UDI-Public: 00022600999393
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2260001996
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown