MAUDE Adverse Event Report: MAVIDON MEDICAL PRODUCTS COLLODION GLUE; SOLVENT, ADHESIVE TAPE

Device Problem Nonstandard Device (1420)

Patient Problem Hair Loss (1877)

Event Date 07/01/2020

Event Type  Injury  

Event Description

I went to see my epilepsy doctor in (b)(6) who conducted a 5 day eeg using mavidon collodion glue and mavidon collodion oil on my entire scalp.I lost over half of my entire hair from the follicle down and still as of (b)(6) 2020 continue to lose my hair in chunks.I reached out to that doctor with concern who told me to just take a zinc vitamin.I reached out to epileptologist and their team is any of their careers have heard of a case of hair loss like mine.They even looked at my head.I had several blood tests done to rule out any other cause and there has been nothing.I continue to lose my hair and mind you i am a (b)(6) year old female with long hair past my shoulders that has decently thick hair and never experienced hair loss or balding.I reached out again to the doctors office who used this product on my entire head who finally gave me the name of the product and manufacturer, i then sent an email to the owner of the company because i ran across this recall on all of their products.The doctors office didn't keep records of the lot numbers and the woman stated she has been using that bottle since she (b)(6) 2019 when she ordered it.They were never aware of the recall, so i wouldn't be surprised if the hair loss is due do the recalled product being used on my head.I have been seeing a regular doctor to make sure there could be no other cause and trying vitamins and hair treatments and waiting on a dermatologist referral to have them help me, because of now i look like i have gone through several rounds of chemo.They need to be investigated by the health department or something needs to occur.Fda safety report id# (b)(4).

• Brand Name: COLLODION GLUE
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): MAVIDON MEDICAL PRODUCTS
• MDR Report Key: 10436788
• MDR Text Key: 204202036
• Report Number: MW5096182
• Device Sequence Number: 1
• Product Code: KOY
• 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
• Report Date: 08/19/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 26 YR
• Patient Weight: 54