MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-11-21 for ADCON-L ANTI-ADHESION BARRIER GEL G0026 manufactured by Gliatech Medical Inc..
[237369]
Around 2000 the pt underwent a revision spinal decompression and fusion. Pt was healthy with no known history of allergies. Within 3 minutes following application of adcon-l, pt developed tachycardia (heart rate elevated from 70-80 bpm to 100-110 bpm) and hypotension (systolic had been about 90 during surgery and dropped to about 70 systolic). The dr reported that he had not given anything else to the pt for about 40 mins prior to application of adcon-l. When the pt was turned, he noted that the pt also had facial swelling. The pt responded well to ephedrine and fluids, but was also given anti-histamines and steroids as a precaution. The event resolved within about 30 mins and the pt did not have further sequelae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2001-00321 |
| MDR Report Key | 361787 |
| Report Source | 05 |
| Date Received | 2001-11-21 |
| Date of Report | 2001-11-21 |
| Date of Event | 2000-02-01 |
| Date Mfgr Received | 2001-10-25 |
| Date Added to Maude | 2001-11-29 |
| 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 | 2001-11-21 |
| 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 | 350943 |
| 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 | 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 | 2001-11-21 |