ACROBAT ARM 241047

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-13 for ACROBAT ARM 241047 manufactured by Ondal.

Event Text Entries

[18191919] Suspension arm supporting liebel-flarsheim high pressure injector broke.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2082246-2002-00001
MDR Report Key402611
Date Received2002-04-13
Date of Event2001-10-22
Date Facility Aware2001-11-19
Report Date2002-04-15
Date Reported to FDA2002-04-15
Date Reported to Mfgr2002-04-12
Date Added to Maude2002-07-03
Event Key0
Report Source CodeDistributor 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 NameACROBAT ARM
Generic NameSUSPENSION ARM
Product CodeIYB
Date Received2002-04-13
Model Number241047
Catalog Number241047
Lot NumberNOT KNOWN
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 YR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key391620
ManufacturerONDAL
Manufacturer Address* HUNFELD GM


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2002-04-13

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