PREPEX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-24 for PREPEX manufactured by Circ Medtech.

Event Text Entries

[68210749] No manufacturer investigation was undertaken since this was a foreseen risk in device usage and is clearly noted both in the ifu and the training program. We have attached a copy of the ifu with the relevant text highlighted.
Patient Sequence No: 1, Text Type: N, H10


[68210750] Patient attempted to self remove device leading to edema was referred to surgical circumcision.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011215095-2017-00905
MDR Report Key6355666
Report SourceUSER FACILITY
Date Received2017-02-24
Date of Report2017-02-24
Date of Event2016-12-10
Date Mfgr Received2017-02-10
Date Added to Maude2017-02-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS OSSIE MILANOV
Manufacturer Street1 HANAGAR ST.
Manufacturer CityHOD HASHARON, 4501305
Manufacturer CountryIS
Manufacturer Postal4501305
Manufacturer Phone97994949
Manufacturer G13BY
Manufacturer StreetTEFEN INDUSTRIAL ZONE
Manufacturer CityTEFEN, 24959
Manufacturer CountryIS
Manufacturer Postal Code24959
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePREPEX
Generic NamePREPEX
Product CodeHFX
Date Received2017-02-24
OperatorNURSE
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCIRC MEDTECH
Manufacturer Address1 HANAGAR ST. HOD HASHARON, 4501305 IS 4501305


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-02-24

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