FDA.reportPublic FDA data

MAUDE MDR 356742

MDR report key
356742
Report number
1530649-2001-00313
Event key
0
Event type
3
Date of event
1998-10-12
Date received
2001-10-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
23420 COMMERCE PARK ROAD CLEVELAND OH 44122 US
Phone
216-216-2168
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADCON-L ANTI-ADHESION BARRIER GELINHIBITOR, PERIDURALGLIATECH MEDICAL, INC.MLQNANAA8236N1(10/12/98) & A8329N1(3/NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-10-1101. R

Event Narratives#

D

Patient 1

THE FIRST SURGERY IN WHICH ADCON-L WAS ON THE FIRST EVENT DATE FOR REDO L3-4, L4-5 AND L5-S1 DECOMPRESSIVE LAMINECTOMY WITH FORMANINOTOMIES AND NERVE ROOT DECOMPRESSION. "ADCON-L WAS PLACED OVER THE EXPOSED NERVE ROOTS." POSTOPERATIVE SYMPTOMS TWO DAYS LATER OCCURRED WHILE IN HOUSE, SEROSANGUINOUS DRAINAGE SATURATED ABD PAD IN 24-HR PERIOD. THE SECOND SURGERY USING ADCON WAS ON THE SECOND EVENT DATE WHICH WAS IDENTICAL TO THE FIRST SURGERY. "THE LATERAL GUTTER'S NERVE ROOT EXITS WERE COVERED WITH A SMALL AMOUNT OF ADCON AT ALL LEVELS." POSTOPERATIVE SYMPTOMS TWO DAYS LATER OCCURRED WHILE IN HOUSE, SEROSANGUINOUS DRAINAGE NOTED; THE NEXT DAY DRAINAGE DECREASED. THE AMOUNTS OF ADCON ADMINISTERED AFTER EACH SURGERY ARE UNKNOWN. NO TREATMENTS WERE GIVEN AND NO DIAGNOSTIC TEST WERE USED POSTOPERATIVELY. THE PT CONTINUES WITH RIGHT LOWER EXTREMITY PAIN.