ENCORE VTU-1 NONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-22 for ENCORE VTU-1 NONE manufactured by Encore, Div. Of Wetoo, Inc..

Event Text Entries

[181353] While attempting to help erectile dysfunction problem on two separate occasions: rptr caused permanent damage to penis, when using the encore vtui erection device. The vacuum pump and constriction rings severely bruised penis, causing a plaque build-up known as peyronie's disease, which causes a severe curvature to the penis preventing rptr from having intercourse with his wife.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1019760
MDR Report Key292050
Date Received2000-08-22
Date of Report2000-08-17
Date of Event1998-11-06
Date Added to Maude2000-08-25
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 NameENCORE VTU-1
Generic NameVACUUM ERECTION DEVICE
Product CodeLKY
Date Received2000-08-22
Model NumberNONE
Catalog NumberNONE
Lot NumberNONE
ID NumberNONE
OperatorOTHER
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key282667
ManufacturerENCORE, DIV. OF WETOO, INC.
Manufacturer AddressP.O. BOX 740668 DALLAS TX 753740668 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2000-08-22

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