MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC TROJAN AROUSES AND RELEASES PERSONAL LUBRICANTS; LUBRICANT, PERSONAL

Model Number	00022600959632
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Inflammation (1932); Pain (1994); Abnormal Vaginal Discharge (2123)
Date of Event	06/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report (2023-cdw-01038, 007801819a) from the united states of america was reported by a 25-year-old female consumer who experienced an inflamed vagina/labia minora, soreness, pain, redness, and discharge and was unable to work after using the trojan arouses and releases personal lubricant.The consumer's medical history was not reported.The concomitant medications included tylenol (acetaminophen), ibuprofen, benadryl (diphenhydramine), lidocaine, and amoxicillin.On (b)(6) 2023 (saturday), the consumer used trojan arouses and releases personal lubricant (not a lot was used) topically (for 1 day).On (b)(6) 2023, she experienced an inflamed vagina, soreness, redness, discharge, and pain in her labia minora.She walked in at urgent care for her treatment and got admitted to the hospital on (b)(6) 2023 (friday).Due to these symptoms, she was unable to work.At the time of this report, she was still experiencing vaginal redness, inflammation, soreness, and pain.No additional information was available.The action taken with trojan arouses and releases personal lubricant was not applicable.The outcome of the events was not recovered.

• Brand Name: TROJAN AROUSES AND RELEASES PERSONAL LUBRICANTS
• Common Device Name: LUBRICANT, PERSONAL
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC; 469 north harrison street; princeton NJ 08543
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 17296200
• Report Number: 2280705-2023-01038
• Device Sequence Number: 17192285
• Product Code: NUC
• UDI-Device Identifier: 00022600959632
• UDI-Public: 00022600959632
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2023

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
• Device Model Number: 00022600959632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/11/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMOXICILLIN; BENADRYL (DIPHENHYDRAMINE); IBUPROFEN; LIDOCAINE; TYLENOL (ACETAMINOPHEN)
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 25 YR
• Patient Sex: Female