MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. CONDOM; TROJAN HER PLEASURE ARMOR

Lot Number TJBF-DP-PURPLE-01

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/16/2023

Event Type  Injury  

Event Description

Used trojan condoms with my partner and we experienced adverse reactions.I am currently in the hospital and have no idea when i'm leaving.Further testing must be conducted to determine diagnosis.Doctors feel that i may have adverse reaction to the product in question.I'm in the hospital and there are several medications.

• Brand Name: CONDOM
• Type of Device: TROJAN HER PLEASURE ARMOR
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.
• MDR Report Key: 16853050
• MDR Text Key: 314375787
• Report Number: MW5117167
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: TJBF-DP-PURPLE-01
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: WOMANS MULTI-VITAMIN
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, American Indian Or Alaskan Native