ALLEN MEDICAL TRANSFER BOARD NOT AVAILABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-10 for ALLEN MEDICAL TRANSFER BOARD NOT AVAILABLE manufactured by Allen Medical Systems.

Event Text Entries

[1246661] Pt was being moved from the operating room table to the bed and found that the allen medical transfer board had a piece of plastic sticking out and not secured. The piece of the transfer board was sharp, so the staff immediately turned to the pt to see if he was injured. They found a 4 inch bleeding wound on the back of the pt. The surgical team was made aware and the wound was addressed. The pt has since healed. After further analysis, the plastic end of the board broke after transfer of the pt. All transfer boards were removed from service.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5013477
MDR Report Key1527188
Date Received2009-11-10
Date of Report2009-11-04
Date of Event2009-10-20
Date Added to Maude2009-11-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALLEN MEDICAL TRANSFER BOARD
Generic NameSURGIBORD
Product CodeFMR
Date Received2009-11-10
Returned To Mfg2009-11-04
Model NumberNOT AVAILABLE
Catalog NumberNOT AVAILABLE
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerALLEN MEDICAL SYSTEMS
Manufacturer AddressONE POST OFFICE SQUARE ACTON MA 01720 US 01720

Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2009-11-10
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