MAUDE Adverse Event Report: CHURCH & DWIGHT CO. REPLENS; LUBRICANT

Lot Number 17064T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Itching Sensation (1943); Nausea (1970); Swelling (2091); Abdominal Cramps (2543)

Event Date 12/01/2016

Event Type  Injury  

Event Description

Used replens as directed for vaginal dryness on wednesday night 9:30.Immediately got very itchy in the vagina.Went to sleep.Woke up feeling ok.Went to work.By mid morning i had very strong stomach cramps, nausea, swelling in face, heavy head, itchiness all over.Was sent by ambulance to emergency.Stomach cramps, got worse by the minute.(b)(6).Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.

• Brand Name: REPLENS
• Type of Device: LUBRICANT
• Manufacturer (Section D): CHURCH & DWIGHT CO.
• MDR Report Key: 6147495
• MDR Text Key: 61616027
• Report Number: MW5066544
• Device Sequence Number: 1
• Product Code: NUC
• 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: 12/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2017
• Device Lot Number: 17064T
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BED TIME 3 SPRAYS BY MOUTH ; DAILY PROBIOTICS 1 TAB TWICE A DAY; ESTROGEN HORMONE ESTRACE TWICE; FOLIC ACID 800MG TWICE A DAY; KY JELLY ; NUTRA SPRAY MELATONIN 1.5MG ONCE BEFORE ; REPLENS ONCE; VIVISCAL HAIR GROWTH EXTRA STRENGTH 1 TAB A DAY
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Weight: 59