UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-05 for UNK manufactured by Unk.

Event Text Entries

[363945] During transfer of the patient from bed to stretcher, the pt's left foot hit a bolt on the metal clamp that holds the trapeze to the bed frame. The pt sustained a 1 inch laceration to the dorsum of the left foot that required sutures.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number524212
MDR Report Key524212
Date Received2004-05-05
Date of Report2004-05-03
Date of Event2004-04-15
Date Facility Aware2004-04-26
Report Date2004-05-03
Date Reported to FDA2004-05-03
Date Added to Maude2004-05-11
Event Key0
Report Source CodeUser Facility 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 FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameBOLT
Product CodeILZ
Date Received2004-05-05
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key513339
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2004-05-05

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