MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-11-09 for ADCON-L ANTI-ADHESION BARRIER GEL G0001 manufactured by Gliatech Medical, Inc..
[210162]
A pt called gliatech's customer service dept to inquire about adcon-l and indicated uses. During the conversation the pt indicated that an anesthesiologist injected adcon-l intrathecally "into the local epidural phase" during a neurolysis procedure being performed on pt. Pt then had excruciating pain and had subsequent temporary paralysis below the waist pt said that pt cannot work as an internist due to the continuing pain that pt is suffering. Pt proclaimed that the medical intervention did not have the appropriate consent in place and signed pt also mentioned that pt underwent a major spinal procedure in 2000 by a neurosurgeon who used adcon-l and everything was just fine. The operative note revealed that the pt had been diagnosed with falied back surgery syndrome with a left l5-s1 radiculopathy. The incident mentioned above occurred during the third stage of a three-stage decompressive neuroplasty. The pt was placed in the left lateral decubitus position. Once informed consent was obtained, iv access was negative aspirate. After 5 minutes, there was no evidence of intravascular or intrathecal injection and an add'l 7cc was then injected. After 20 minutes, an infusion of hypertonic saline was started and ran in over 30 minutes to an infusion of 10cc. The catheter was then flushed with 1 cc of preservative free normal saline. Then 4cc of adcon gel was injected through the catheter. This was then flushed with 1cc of preservative free normal saline. The catheter was removed. Band-aid was placed after the area was cleaned and the pt recovered without incident, according to the operative note.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2001-00317 |
| MDR Report Key | 360742 |
| Report Source | 05 |
| Date Received | 2001-11-09 |
| Date of Report | 2001-11-09 |
| Date of Event | 1999-10-28 |
| Date Added to Maude | 2001-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 23420 COMMERCE PARK ROAD |
| Manufacturer City | CLEVELAND OH 44122 |
| Manufacturer Country | US |
| Manufacturer Postal | 44122 |
| Manufacturer Phone | 2168313200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADCON-L ANTI-ADHESION BARRIER GEL |
| Generic Name | INHIBITOR, PERIDURAL |
| Product Code | MLQ |
| Date Received | 2001-11-09 |
| Model Number | NA |
| Catalog Number | G0001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 349914 |
| Manufacturer | GLIATECH MEDICAL, INC. |
| Manufacturer Address | 23420 COMMERCE PARK RD. CLEVELAND OH 44122 US |
| Baseline Brand Name | ADCON-L ADHESION CONTROL IN A BARRIER GEL |
| Baseline Generic Name | INHIBITOR, PERIDURAL FIBROSIS |
| Baseline Model No | NA |
| Baseline Catalog No | G0001 |
| Baseline ID | NA |
| Baseline Device Family | ADCON-L ADHESION CONTROL IN A BARRIER GEL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9600 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-11-09 |