D ARSENVAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-13 for D ARSENVAL manufactured by Skinrecharge Llc.

Event Text Entries

[1010970] The translation of instructions for use were written by a non-medical person. The face sculptor did not work and had no results. It was supposed to tone facial muscles, help with blood circulations, firm skin. D arsenval professional was supposed to help with hemorrhoids, help with blood circulations, help with coughs, caused red spots, help with hair loss, increases heart rate and help with headaches. It has fragile glass tips. Distributor's instructions were to just leave the glass tips in the electric handle, as they were experiencing similar tip breakage problems with other units. Vibronetiks platform aggravated liver problems, doubled knee problems, increased arrythmia problems, was to increase blood flow/circulation by loosing the materials on atrial walls, increase oxygen flow. Dates of use: 2008 - 2009. Diagnosis: 1. Tone muscles, help with blood circulations, firm skin. 2. Help with hemorrhoids, help with blood circulations, help with. The face sculptor arrived in late 2008. The boxes factory seals were broken when they arrived, indicating that they had been opened before shipment to me. When i asked them about this, they said it was because they needed to inspect the units check and see if the batteries were leaking. The ones shipped to me arrived without batteries. The face sculptor was returned to them in early 2009. The d arsenval unit - i had already sent them the broken unit. They had sent me a replacement for the broken glass part in late 2008 and, at no additional cost, a second electric handle. Their instructions were to just leave the glass tips in the electric handle, as they were experiencing similar breakage problems with other units.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5010028
MDR Report Key1317551
Date Received2009-02-13
Date of Report2009-02-13
Date of Event2008-11-28
Date Added to Maude2009-03-12
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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameD ARSENVAL
Generic NameFACE SCULPTOR
Product CodeIRO
Date Received2009-02-13
Returned To Mfg2009-01-24
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerSKINRECHARGE LLC
Manufacturer Address16-23 RIVER RD #C FAIR LAWN NJ 07410 US 07410

Device Sequence Number: 2

Brand NameD ARSENVAL PROFESSIONAL
Generic NameVIBRONETIKS
Product CodeIRO
Date Received2009-02-13
Returned To Mfg2009-01-24
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Sequence No2
Device Event Key0
ManufacturerSKINRECHARGE LLC
Manufacturer Address16-23 RIVER RD #C FAIR LAWN NJ 07410 US 07410


Patients

Patient NumberTreatmentOutcomeDate
10 2009-02-13

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