MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-10-11 for ADCON-L ANTI-ADHESION BARRIER GEL manufactured by Gliatech Medical Inc..
[219406]
Adcon was applied after surgery in 2000. The procedure was a redo of a left l4-5 and l5-s1, and new right l4-5 and l5-s1 laminotomy, foraminotomy, and nerve root decompression. The amount of adcon applied is not known. The pt's postoperative symptoms began 3 days later, while "in-house" the pt developed a slight serous drainage. The pt was discharge home the same day with keflex 500 mg four times a day (#20). The drainage lasted until about the 10th post op day. At the first follow-up visit the next week, no drainage was observed. The wound had no redness or swelling. No other investigation were performed other than a 5-day course of keflex. The present status of the pt is a continuation of left lower extremity aching and a general progression of symptoms from 09/2000 to 12/2000. A repeat mri (12/2000) showed left l4-5 and l5-s1 bulges with lid to moderate foraminal stenosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2001-00312 |
| MDR Report Key | 358190 |
| Report Source | 05 |
| Date Received | 2001-10-11 |
| Date of Report | 2001-10-11 |
| Date of Event | 2000-02-14 |
| Date Mfgr Received | 2001-09-06 |
| Device Manufacturer Date | 1999-11-01 |
| Date Added to Maude | 2001-10-30 |
| 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 | 2001-10-11 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | A9328N1 |
| ID Number | NA |
| Device Expiration Date | 2001-10-01 |
| 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 | 347397 |
| Manufacturer | GLIATECH MEDICAL INC. |
| Manufacturer Address | 23420 COMMERCE PARK RD. CLEVELAND OH 44122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-10-11 |