BREEZY 18" INV DLW 228104 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-10 for BREEZY 18" INV DLW 228104 UNKNOWN manufactured by Sunrise-medical Quickiee.

Event Text Entries

[13240] Sustained 2 1/2 inch long by 1/2 inch deep laceration to right lower leg, inner aspect above ankle. Believed to have been caused by wheelchair.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number25471
MDR Report Key25471
Date Received1995-01-10
Date of Report1994-09-08
Date of Event1994-09-08
Date Facility Aware1994-09-08
Report Date1994-09-09
Date Added to Maude1995-09-14
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 NameBREEZY 18"
Generic NameWHEELCHAIR
Product CodeKID
Date Received1995-01-10
Model NumberINV DLW 228104
Catalog NumberUNKNOWN
Lot NumberNI
ID NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key25969
ManufacturerSUNRISE-MEDICAL QUICKIEE
Manufacturer Address2842 BUSINESS PARK AVE. FRESNO CA 93727 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1995-01-10

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