MAUDE Adverse Event Report: CHURCH & DWIGHT CO., REPLENS VAGINAL MOISTURIZER DISPOSABLE APPLICATORS; LUBRICANT, PERSONAL

Model Number	00022600001041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Cough (4457); Unspecified Respiratory Problem (4464)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not avail.
Event or Problem Description
This spontaneous report ((b)(4)) from the united states of america was reported by a 64-year-old female consumer via the health authority (fda medwatch program) and followed up by a survey, who reported severe urinary tract infection, chest congestion, and cough after using the replens vaginal moisturizer reusable applicator.On an unspecified date (prior to the symptoms starting), the consumer initiated replens vaginal moisturizer reusable applicator weekly (about 4 applications), topically.On (b)(6) 2024, after using the product, she reported being diagnosed with a severe urinary tract infection.In addition, she suffered from respiratory symptoms (chest congestion and cough).After that, she sought medical attention in the emergency room and was prescribed antibiotics (unspecified).Later, she stopped using the product.At the time of this report her symptoms had persisted.No additional information was available.The action taken with replens vaginal moisturizer reusable applicator was not applicable.The outcome of the events was not recovered.
Event or Problem Description
This spontaneous report (2024-cdw-02283, 07370091) from the united states of america was reported by a 64-year-old female consumer via the health authority (fda medwatch program) and followed up by a survey, who reported severe urinary tract infection, chest congestion, and cough after using the replens vaginal moisturizer reusable applicator.On an unspecified date (prior to the symptoms starting), the consumer initiated replens vaginal moisturizer reusable applicator weekly (about 4 applications), topically.On (b)(6) 2024, after using the product, she reported being diagnosed with a severe urinary tract infection.In addition, she suffered from respiratory symptoms (chest congestion and cough).After that, she sought medical attention in the emergency room and was prescribed antibiotics (unspecified).Later, she stopped using the product.At the time of this report her symptoms had persisted.No additional information was available.The action taken with replens vaginal moisturizer reusable applicator was not applicable.The outcome of the events was not recovered.Follow-up (fu1): a correction was performed on (b)(6) 2026 to revise the reportability assessment.Upon re-evaluation of the available information, the reported events (severe urinary tract infection, chest congestion, and cough) were determined not to meet fda mdr serious injury reporting criteria.Therefore, the case was downgraded to non-serious/non-reportable (previously submitted as serious/reportable).
Additional Manufacturer Narrative
Not avail.

• Brand Name: REPLENS VAGINAL MOISTURIZER DISPOSABLE APPLICATORS
• Common Device Name: LUBRICANT, PERSONAL
• Manufacturer (Section D): CHURCH & DWIGHT CO.,; 469 north harrison street; princeton NJ 08543
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC; 500 charles ewing boulevard; ewing NJ
• Manufacturer Contact: tracy dunn ; 469 north harrison street; princeton, NJ
• MDR Report Key: 21134579
• Report Number: 2280705-2024-02283
• Device Sequence Number: 7464835
• Product Code: NUC
• 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,Followup
• Report Date (Section B): 06/09/2026

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: 00022600001041
• Device Catalogue Number: NOT AVAIL.
• Device Lot Number: KK407301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT AVAIL.
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIRBORNE EFERVESCENT TABLETS; AIRBORNE EFERVESCENT TABLETS.; ALBUTEROL SULFATE AEROSOL; ALBUTEROL SULFATE AEROSOL.; AMLODIPINE BESYLATE 5 MG; AMLODIPINE BESYLATE 5 MG.; CLARITHROMYCIN 500 MG; CLARITHROMYCIN 500 MG.; FLONASE SENSIMIST; FLONASE SENSIMIST.; IPRATROPIUM BROMIDE 0.06%; IPRATROPIUM BROMIDE 0.06%.; METFORMIN 500 MG; METFORMIN 500 MG.; TYLENOL; TYLENOL.; VITAMIN C 1000 MG; VITAMIN C 1000 MG.; VITAMIN D (1000 UI); VITAMIN D (1000 UI).; ZYRTEC; ZYRTEC.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 134 LB
• Patient Race: White