MAUDE Adverse Event Report: POLICHEM SA GYNATROF; LUBRICANT, PERSONAL

Lot Number 2732

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Abnormal Vaginal Discharge (2123)

Event Date 03/19/2023

Event Type  Injury  

Event Description

Excessive vaginal sloughing and large amounts of vaginal cellular debris as white, rubbery clumps of tissue, leaving behind a raw, dry vaginal lining from use of gynatrof gel after only two applications.I have no history of yeast infection for over 30 years.I do not believe the manufacturer's "sometimes shedding old dry tissue" explanation, because if true, it should happen with most or all users, not just some.I think it's a common allergy or sensitivity to an ingredient.This is similar to sloughing i experienced with products containing nonoxynol-9.I have not reported to the manufacturer yet because it's the weekend, but i intend to.The same reaction is frequently reported with a similar product, replens, of which gynetrof is an imitator with a similar formulation.(see the replens reviews on drugs.Com.) i don't doubt it's a good product that helps a lot of people, but i think it's irresponsible of the manufacturers to dismiss concerns about discharge as normal, potentially causing further exposure to an allergic trigger, or delayed treatment for another condition like yeast infection.If they can't provide better information about what is and isn't a normal reaction on their product insert and website, it would be better they said nothing at all.

Event Description

Additional information received on 4/12/2023 for mw5115895 to update mfr.(b)(4).

• Brand Name: GYNATROF
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): POLICHEM SA
• MDR Report Key: 16590200
• MDR Text Key: 311828149
• Report Number: MW5115895
• Device Sequence Number: 1
• Product Code: NUC
• 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,Followup
• Report Date: 03/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 2732
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White