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..
[210121]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2001-00313 |
| MDR Report Key | 356742 |
| Report Source | 05 |
| Date Received | 2001-10-11 |
| Date of Report | 2001-10-11 |
| Date of Event | 1998-10-12 |
| Date Mfgr Received | 2001-09-06 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 2001-10-23 |
| 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 | A8236N1(10/12/98) & A8329N1(3/ |
| ID Number | NA |
| Device Expiration Date | 2000-07-01 |
| 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 | 345971 |
| 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 |