ADCON-L ANTI-ADHESION BARRIER GEL G0026

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-05-03 for ADCON-L ANTI-ADHESION BARRIER GEL G0026 manufactured by Gliatech Medical, Inc..

Event Text Entries

[17907018] On 4/2002, a gliatech employee received an email from the qa/ra representative of forth medical (uk distributor) stating that consultant neurosurgeon informed their representative of an incident that they had recently experienced using adcon-l. Consultant operated on a patient and used adcon-l. In the immediate post operative phase, the patient experienced severe pain (nerve root pain) and an epidural anesthetic was used to relieve the symptoms. Consultant's own opinion was that there may have been a reaction between the gel and the patient's disc material, perhaps the annulus. Consultant states that this is their third incidenct of postoperative pain following the use of adcon. No further information is currently available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1530649-2002-00014
MDR Report Key392130
Report Source05
Date Received2002-05-03
Date of Report2002-05-03
Date Mfgr Received2002-04-23
Date Added to Maude2002-05-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Location0
Manufacturer Street23420 COMMERCE PARK ROAD
Manufacturer CityCLEVELAND OH 44122
Manufacturer CountryUS
Manufacturer Postal44122
Manufacturer Phone2168313200
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADCON-L ANTI-ADHESION BARRIER GEL
Generic NameINHIBITOR, PERIDURAL
Product CodeMLQ
Date Received2002-05-03
Model NumberNA
Catalog NumberG0026
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key381159
ManufacturerGLIATECH MEDICAL, INC.
Manufacturer Address23420 COMMERCE PARK RD. CLEVELAND OH 44122 US
Baseline Brand NameADCON-L ADHESION CONTROL IN A BARRIER GEL
Baseline Generic NameINHIBITOR, PERIDURAL FIBROSIS
Baseline Model NoNA
Baseline Catalog NoG0026
Baseline ID3 GRAMS IN SYRI
Baseline Device FamilyADCON-L ADHESION CONTROL IN A BARRIER GEL
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]24
Baseline PMA FlagY
Premarket ApprovalP9600
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2002-05-03

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