MAVIDON COLLODION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for MAVIDON COLLODION manufactured by Mavidon Medical Products.

Event Text Entries

[185928079] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093977
MDR Report Key9903020
Date Received2020-03-30
Date of Report2020-03-27
Date of Event2019-07-21
Date Added to Maude2020-03-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAVIDON COLLODION
Generic NameDEGREASER, SKIN, SURGICAL
Product CodeKOY
Date Received2020-03-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMAVIDON MEDICAL PRODUCTS


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-03-30

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