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 2002-04-26 for ADCON-L ANTI-ADHESION BARRIER GEL G0026 manufactured by Gliatech Medical Inc..

Event Text Entries

[21250542] In 2002, gliatech received a letter from the ra/qa rep at distributor stating that a "few weeks ago" she had a conversation with hosp. During the conversation, hosp requested the address for allergy diagnostic (a testing facility which performs anti-gelatin ige tests) so that she could, "send a blood sample from a pt who showing a symptoms of hypotension following application of adcon-l". Per the ra/qa rep, at that time, hosp did not wish to file a complaint. Distributor then sent a letter requesting info and they received a return letter from hosp. In the letter hosp stated, "i spoke with dr regarding my inquiry: the pt concerned was operated in the private sector and not their hosp. Dr has informed me that all the test results were negative and was not an immediate reaction but occurred several hours later, and was not related to adcon-l". No further details are available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1530649-2002-00011
MDR Report Key390459
Report Source05
Date Received2002-04-26
Date of Report2002-04-26
Date Mfgr Received2002-03-28
Date Added to Maude2002-04-30
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 Location3
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 Received2002-04-26
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 Key379508
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. Life Threatening 2002-04-26

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