MAUDE Adverse Event Report: MAVIDON MEDICAL PRODUCTS MAVIDON COLLODION; DEGREASER, SKIN, SURGICAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hair Loss (1877); Hemorrhage/Bleeding (1888); Irritation (1941); Burning Sensation (2146); Tingling (2171); Depression (2361)

Event Date 07/21/2019

Event Type  Injury  

Event Description

I went to the neurologist for an eeg and the lady soaked my whole head with the collodion i left there with a wet head i freaked out the 1st 30/45 mins.I had no idea why my head was tingling in the whole time.It ended up killing all of my hair and burnt my scalp.Apparently now i have been diagnosed with dermatitis and alopecia due to this incident.Not only did they not use this product in the way they were trained to use it they did not have a ventilation system which is required by law in order to use this product on pts.The lady kept asking me while she was putting it on if i was ok and it was burning.Man, my nose bled for 8 hrs straight while the product was on my head for an ambulatory e.G, which they were not able to get a conclusive reading due to neglect by the physician's assistant.What little of my hair has grown back is growing very dry and slow, it looks like i stuck my finger a socket.This lady took away the image that i had of myself, i feel like a look like a boy now, am very depressed because she took away 3 yrs of hard work for me to grow my hair out, i didn't blow dry it, dye it, curling straightening or anything for 3 yrs just so it would grow long and healthy and it was past my shoulders thick with no split ends and now there is just damage and split ends and it just breaks off and falls out.I want my hair back.Absorbed through scalp; i miss my hair.Fda safety report id# (b)(4).

• Brand Name: MAVIDON COLLODION
• Type of Device: DEGREASER, SKIN, SURGICAL
• Manufacturer (Section D): MAVIDON MEDICAL PRODUCTS
• MDR Report Key: 9903020
• MDR Text Key: 185928079
• Report Number: MW5093977
• 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: 03/27/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 66