ADCON-L GLIATECH *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-25 for ADCON-L GLIATECH * manufactured by Gliatech.

Event Text Entries

[265981] In 1999 - medical device adcon-l. Packing - aluminum. Now developing alzheimer's like syndrome. Adcon-l-injected in left l5 - s1 epidural spinal. Near as death in 2002. Not reported by md.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1027978
MDR Report Key450835
Date Received2003-03-25
Date Added to Maude2003-04-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameADCON-L GLIATECH
Generic Name*
Product CodeMLQ
Date Received2003-03-25
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key439833
ManufacturerGLIATECH
Manufacturer Address* CLEVELAND OH * US


Patients

Patient NumberTreatmentOutcomeDate
10 2003-03-25

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