FERNO BACKBOARD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-10-08 for FERNO BACKBOARD manufactured by Ferno-washington, Inc..

Event Text Entries

[21635174] Customer claims board broke in two. No injuries.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1523574-1997-00129
MDR Report Key126214
Report Source05
Date Received1997-10-08
Date of Report1997-09-04
Date Mfgr Received1997-09-04
Date Added to Maude1997-10-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFERNO BACKBOARD
Generic NameBACKBOARD
Product CodeFPS
Date Received1997-10-08
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key123538
ManufacturerFERNO-WASHINGTON, INC.
Manufacturer Address70 WEIL WAY WILMINGTON OH 45177 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-10-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.