UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-09 for UNK * manufactured by Unk.

Event Text Entries

[205804] Rptr writes: dermal changes. Post dermabrasion side effects - serious adverse events, both from the standpoint as to what this has led to physically (damage, and persistent and permanent change to skin and facial features, etc) but also the tremendous emotional burden and psychological trauma it's done to my life! This issue alone has altered the quality of my life. It has, among other things - i am afraid, invariably contributed to bad personal habits and obsessions - be it in trying to control the problem, and, or to hide or escape from it! I often times feel like a "recluse" and a "freak". Sufferer wonders if not a skin condition; perhaps permanent, is not the result of: (in layman's terms) = some "hyper stimulation," if you will of sebaceous glands or allergic reaction, or infection, like perhaps herpes simplex or colated clinical entity? Is inflammation, and clusters of closed comedones/papulars (or pus). Not easily concealed with tinted acne coverup, or makeup (which of course is socially unacceptable. It is painful, and disfiguring - and is ongoing (chronic) problem; causing great discomfort, and embarrassment? As such, i find myself retreating from as much social contact, as possible, i. E. , self-imposed isolation, for the most part. Venturing out only when necessary and or limiting the most intimate of person to person contact, and hiding my face with caps, bandanas, hood, sunglasses, etc which is to not expose others to my dreaded looks, and to help "shield" myself from others, which may just have opposite effect)?!
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1018161
MDR Report Key263347
Date Received2000-02-09
Date of Report1999-11-01
Date of Event1981-01-01
Date Added to Maude2000-02-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameDERMABRADOR
Product CodeGFE
Date Received2000-02-09
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key254943
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2000-02-09

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