DIAMOND TONE/NEW APEEL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-19 for DIAMOND TONE/NEW APEEL * manufactured by Altair Instruments.

Event Text Entries

[331311] Pt had a microdermabrasion done at a dr's office and the unit/wand was run over their eyelids and right underneath the eye. Normal "midroderms", do not do this on the eyelid. That area is too delicate and can damage. Pt was not told they were going to do this on the upper eyelid. Later that week, both eyelids turned bright red and had small welt-like abrasions and the eyelids were swollen and sore. Pt went to a dr, dermatologist and finally an ophthamologist, because the vision in left eye was distorted. No permanent damage to the eye, but after a month and this finally healed, the skin on the eyelid was clearly damaged. The upper eyelid skin is now stretched and loose, as is the skin under the eye. The manufacturer of the product -diamond tone/new appeal- told pt it is stated in their manual that the wand can be used over the eyelid and under the eye, if the vacuum is turned off. That was not the case during pt's microdermabrasion. The machine was on and damage occurred. The only way to repair the problem is to have a plastic surgeon repair. Reporter feels manufacturer should not use this product over the eyelids if they cannot assure that the user will not have the vacuum off. Now pt is left with a problem they cannot afford to pay for. Reporter feels this is not a safe procedure when the user can violate instructions. The manufacturer should be responsible for allowing usage over the eyelid when the vacuum can cause damage.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1029613
MDR Report Key488476
Date Received2003-09-19
Date of Report2003-09-19
Date of Event2002-11-02
Date Added to Maude2003-10-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDIAMOND TONE/NEW APEEL
Generic NameMICRODERMABRASION MACHINE
Product CodeGFE
Date Received2003-09-19
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key477317
ManufacturerALTAIR INSTRUMENTS
Manufacturer Address321 N. AVIADOR-STE 113 CAMARILLO CA 93010 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2003-09-19

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