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 05 report with the FDA on 2001-11-15 for ADCON-L ANTI-ADHESION BARRIER GEL G0001 manufactured by Gliatech Medical Inc..

Event Text Entries

[211115] Gliatech recently rec'd a letter from a neurosurgeon concerning his experiences with adcon-l. In the letter he mentions one event that occurred out of 130 of his pts. The following is taken from the letter: "reporter has used adcon in 130 pts: 119 pts underwent surgery for a peripheral nerve problem and 11 underwent lumbar spine surgery. In these 130 pts, only 1 developed a problem attributable to the adcon: a sterile fluid accumulation following a surgical decompression of the radial nerve in the forearm. A reoperation was performed for drainage of the fluid which demonstrated no scarring at the site of surgery. A smooth capsule surrounding the fluid was resected and pathology demonstrated findings of a foreign body reaction: this pt was allergic to many substances. The pt improved clinically following these surgeries. " further info was obtained from the dr which detailed the incident. The pt underwent decompression and neurolysis of right radial nerve in the proximal forearm with intraoperative placement of adcon gel in 1999. The pt did well until 2 mos later when the pt noticed a soft painless lump at the surgical site. The lump has gradually increased in size. The pt has not experienced any change in strength or sensation in right upper extremity. The pt was admitted to the hosp and underwent both an ultrasound and mri which revealed a large fluid cavity in a complex cystic configuration, with perhaps a septation within it. The pt was admitted to the hosp and several cc's of cyst fluid were obtained through a needle aspiration. The fluid was found to be yellow and clear. A gram's stain was performed, which did not reveal any organisms. The pt was then started on iv kefzol prior to surgery. Description of procedure: pt rec'd an add'l gram of kefzol, just prior to the procedure. The old surgical site was prepped using betadine solution. After 25 cc of local anesthetic was injected in the old surgical incision (50%, 1% lidocaine with epineprhine + 50%m 1% marcaine diluted to a 1 to 10 ratio with sodium bicarbonate). The old incision was re-incised. "as they dissected through the subcutaneous tissue, they encountered capsular tissue, which was punctured. An add'l 10 cc of fluid was sent for diagnostic studies. The fluid appeared yellow and clear. " the wound was further opened by partially excising the capsular tissue. All the fluid drained out. The surrounding tissues appeared smooth and shiny and "there did not appear to be any significant adhesions". The wound was then inspected and excellent hemostatis was achieved. The wound was irrigated with copious amounts of normal saline containing bacitracin. The wound was then closed. The pt returned home and suffered a recurrent accumulation of fluid in a cystic configuration and had to have it drained periodically. The pt experienced increased soreness along right volar forearm. The pt also complains of shooting pains that extend proximally up to axilla and down to the fingers of right hand. In 1999 the pt went back the pt's original dr who stated "i could palpate a fullness over the pt's surgical site, but definite evidence of fluid. There was no erythema to suggest an on-going infection. The pt continues to demonstrate normal sensation in a distal right radial nerve distribution. I attempted to percutaneously aspirate fluid from the surgical region: however, i was unsuccessful. " the patient continued to suffer from painful symptoms, as well as fluctuating mass in right colar forearm. The pt was seen in the next month. Since the pt's last visit two weeks ago, the pt has noticed a reduction of pain in the pt's right forearm and improved function. The pt's physical exam continues to demonstrate 4 to 4+/5 strength in right radial nerve supplied muscles. The dr could not detect any fullness at the operative site. The pt underwent an ultrasound that day which did not reveal any evidence of underlying fluid. The dr concluded by saying: "i think patient is beginning to make a good recovery from the pt's surgery. Hopefully, the fluid will no longer reaccumulate. I have made plans to see the pt in two months time in order to continue monitoring the progress. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1530649-2001-00320
MDR Report Key361051
Report Source05
Date Received2001-11-15
Date of Report2001-11-15
Date of Event1999-08-16
Date Mfgr Received2001-11-01
Date Added to Maude2001-11-27
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 Received2001-11-15
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 Key350205
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 2001-11-15

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