UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-11 for UNK manufactured by Unk.

Event Text Entries

[18911332] Bucks traction was applied incorrectly to pt causing increased pain.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number647687
MDR Report Key647687
Date Received2005-11-11
Date of Report2005-11-09
Date of Event2005-07-26
Date Facility Aware2005-11-09
Report Date2005-11-09
Date Reported to FDA2005-11-09
Date Added to Maude2005-11-29
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 NameBUCKS TRACTION
Product CodeHSP
Date Received2005-11-11
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key637175
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2005-11-11

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