UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-27 for UNK * manufactured by Medegen Medical Products.

Event Text Entries

[17889366] Cut found on underside of glans penis due to sharp edge of urinal.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1336026
MDR Report Key1336026
Date Received2009-02-27
Date of Report2009-02-24
Date of Event2009-02-05
Report Date2009-02-24
Date Reported to FDA2009-02-27
Date Added to Maude2009-03-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameMALE URINAL
Product CodeFNP
Date Received2009-02-27
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMEDEGEN MEDICAL PRODUCTS
Manufacturer Address209 MEDEGEN DRIVE GALLOWAY TN 38036 US 38036


Patients

Patient NumberTreatmentOutcomeDate
10 2009-02-27

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