MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-11-01 for ADCON-L ANTI-ADHESION BARRIER GEL G0026 manufactured by Gliatech Medical, Inc..
[242603]
Description of surgery: l3-l4-l5 spinal decompression and fusion. Position of pt: prone. Length of surgery: 3 hours, 20 minutes. Timeframe between application of adcon-l and onset of symptoms: less than 30 seconds. Pt symptoms: "pt anesthetized, unable to determine symptoms. " signs were: 1. Hypotension- sbp fell from 120mm hg to 50mm hg. 2 rash- arms and shoulders, red flush. No pattern. 3 heart rate- rises from 60 cb/min to 100 cb/min (sinus tachycardia). 4. No difficulty in oxgenating or ventilating pt. No evidence of bronchospasm (normal lung inflation pressures). Treatment: 1. 100% oxygen 2. Hartmann's (ringer lactate) 1000 ml, hetastarch 6% in normal saline 500 3. Adrenaline 5ml in 1/10,000u 4. Armine 10mg length of time between onset of symptoms and resolution approx. 20 minutes. Status of pt: "drowsy (post anesthetic) but coherent, cardiovascularly normal (p and bp) stable, spontaneous ventilation (35 degrees t, o2 saturation 97%), no residual rash. " diagnostic tests performed: ige, tryptase, and clotting screen.
Patient Sequence No: 1, Text Type: D, B5
[16361352]
The dr reported that on event date he had a problem with a pt who virtually immediately after the application of adcon-l developed profound hypotension. The surgery was a routine spinal decompression (multi-level). The dr stated that the anesthetist usually maintains the bp around 80 during the procedure. Towards the end, the bp is raised back to the pt's normal bp (in this case, about 130). Around that time, 3 grams of adcon was applied. The blood pressure dropped to 40 about 60 seconds after application. There was not a skin rash or any external signs of reaction. The event required resuscitation with adrenaline and colloids. Epinephrine was administered. The pressure drop lasted about 4 to 5 minutes, then returned to normal. They did not washout the adcon-l. The event resolved without sequelae and the pt made a good recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2001-00315 |
| MDR Report Key | 359969 |
| Report Source | 05 |
| Date Received | 2001-11-01 |
| Date of Event | 2001-09-27 |
| Date Mfgr Received | 2001-10-04 |
| Date Added to Maude | 2001-11-16 |
| 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 | 2001-11-01 |
| 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 | 349151 |
| 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 | 2001-11-01 |