MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2003-01-22 for ADCON-L ANTI-ADHESION BARRIER GEL manufactured by Gliatech Medical Inc..
[20520297]
A physician reported a case of hypotension. A patient (weight, 85kg) had a "fall in blood pressure from systolic pressure of 110 to 60 mmhg within 2-3 minutes following instillation of adcon gel into laminectomy wound at end of case". The patient had a "rapid response to vasopressin, fluids and removal of gel from the wound". Dr. Considered this situation to be "life-threatening". The patient had no known drug allergies and no history of elevated blood pressure. The patient had non-insulin dependent diabetes mellitus. The patient was taking the following medications: atenolol, ramipril, bendrofluaziol, and metformin. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2003-00001 |
| MDR Report Key | 439551 |
| Report Source | 00,01 |
| Date Received | 2003-01-22 |
| Date of Report | 2003-01-22 |
| Date Mfgr Received | 2002-11-18 |
| Date Added to Maude | 2003-01-28 |
| 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 | 2003-01-22 |
| Model Number | NA |
| Catalog Number | NA |
| 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 | 428490 |
| Manufacturer | GLIATECH MEDICAL INC. |
| Manufacturer Address | 23420 COMMERCE PARK ROAD CLEVELAND OH 44122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2003-01-22 |