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

Model Number 00022600959632

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Inflammation (1932); Pain (1994); Abnormal Vaginal Discharge (2123)

Event Date 06/18/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 318745165
• Report Number: 2280705-2023-01038
• Device Sequence Number: 1
• Product Code: NUC
• UDI-Device Identifier: 00022600959632
• UDI-Public: 00022600959632
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 00022600959632
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: AMOXICILLIN; BENADRYL (DIPHENHYDRAMINE); IBUPROFEN; LIDOCAINE; TYLENOL (ACETAMINOPHEN)
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR
• Patient Sex: Female