ADCON-L ANTI-ADHESION BARRIER GEL G0001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-05-03 for ADCON-L ANTI-ADHESION BARRIER GEL G0001 manufactured by Gliatech Medical, Inc..

Event Text Entries

[16145777] On 04/2002, a gliatech employee received a "notice of product liability claims" from attorney. The letter states that, "the claims related to batches of adcon-l which were the subject of a product recall. The co's clients all underwent disc surgeries in the fall of 2000. All three individuals were treated with batches of adcon-l which were subsequently recalled. As you know, the recall was prompted by findings that packages containing adcon-l were contaminated, at a minimum, with aluminum shavings. All three individuals developed serious infections shortly after administration of adcon-l. It is the co's belief that the co's clients' infections were caused by contaminated adcon-l and they are entitled to compensation. " no additional information is currently available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1530649-2002-00013
MDR Report Key392071
Report Source00
Date Received2002-05-03
Date of Report2002-05-03
Date Mfgr Received2002-04-22
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
Reporter OccupationATTORNEY
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 NumberG0001
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key381100
ManufacturerGLIATECH MEDICAL, INC.
Manufacturer Address23420 COMMERCE PARK ROAD CLEVELAND OH 44122 US
Baseline Brand NameADCON-L ADHESION CONTROL IN A BARRIER GEL
Baseline Generic NameINHIBITOR, PERIDURAL FIBROSIS
Baseline Model NoNA
Baseline Catalog NoG0001
Baseline IDNA
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.