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 G0026 manufactured by Gliatech Medical Inc..
[21710201]
Recently members of gilatech met with a doctor who performs in the united kingdom. In the meeting with the doctor he claimed that there were no hypotensive events to report. A leter meeting with his anesthetist revealed that in fact he thought there had been. The anesthetist said that the event should be classified as profound hypotension (bp dropping to 50 mm). The anesthetist said that it was their belief at the time of the events that the events were tied to the doctor's surgical practices (the use of an epidural anesthetic, a local cocktail, at closing). No specific patient details were given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2001-00318 |
| MDR Report Key | 360782 |
| Report Source | 05 |
| Date Received | 2001-11-09 |
| Date of Report | 2001-11-09 |
| Date Mfgr Received | 2001-10-05 |
| Date Added to Maude | 2001-11-26 |
| 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 | G0026 |
| 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 | 349940 |
| Manufacturer | GLIATECH MEDICAL INC. |
| Manufacturer Address | 23420 COMMERCE PARK ROAD 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 | G0026 |
| Baseline ID | 3 GRAMS IN SYRI |
| 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 |