OASIS ELITE * EL141

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-06 for OASIS ELITE * EL141 manufactured by Trulife.

Event Text Entries

[295450] This pt underwent a multi-level lumbar spine fusion and was prone for approximately 8 hours on a jackson table. Their face was padded with a gel ring. At the end of the procedure it was noted that there was an area of indentation on the pt's forehead. The skin broke down in the area, and it is undetermined what the ultimate cosmetic result will be.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number487905
MDR Report Key487905
Date Received2003-10-06
Date of Report2003-06-01
Date of Event2003-04-01
Date Added to Maude2003-10-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
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 NameOASIS ELITE
Generic NamePRONE HEADREST
Product CodeKME
Date Received2003-10-06
Model Number*
Catalog NumberEL141
Lot Number*
ID Number*
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key476764
ManufacturerTRULIFE
Manufacturer AddressPO BOX 89 JACKSON MI 49204 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-10-06

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