MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-09-27 for ADCON-L ANTI-ADHESION BARRIER GEL G0026 manufactured by Gliatech Medical, Inc..
[16268856]
The episode occurred on a pt after a discectomy. Post-operatively, there was an episode of an acute fibrinolysis requiring a return of the pt to surgery because of an hematoma and for pharmacological compensation (pfc, fibrinogen). They could not detect or identify the caus of this fibrinolysis episode which was on the other hand totally regressive after surgical and drug treatment. No unusual drug therapy regressive after surgical and drug treatment. No unusual drug thereapy was administered to the pt as far as the anesthesiology point of view is concerned. Adcon-l was administered in situ by the surgeon. A conversation with the doctor revealed the folowing: the pt developed a very hematoma one hour folowing surgery with adcon-l. The pt was re-operated within 1. 5 hours of the surgery. At reoperation the doctor saw nothing unusual. He cauterized some bleeding vessels and washed out the wound. The pt was discahrged without further sequelae. He cauterized some bleeding vessels and washed out the wound. The pt was discharged without further sequelae. The doctor saw the pt at one-week following surgery and the pt continued to do well. The doctor believes this is isoled and has hand no further problems with adcon.
Patient Sequence No: 1, Text Type: D, B5
[20516719]
On 08/2001 gliatech rec'd an email from reporter, vice administration finances of sulzer orthopedic, their french distributor stating that "reporter received the declaration of materiovigilancy (incident declaration to their regulatory authority) to afssaps (govermmental health authority)". This declaration will be sent by the french authority to the fda. He stated that the incident occurred at the on overseas hospital where a pt had an infection, but they were not certain if it was related to adcon-l. After repetitive inquiry no further info was obtained from reporter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2001-00301 |
| MDR Report Key | 353694 |
| Report Source | 08 |
| Date Received | 2001-09-27 |
| Date of Report | 2001-09-27 |
| Date of Event | 2001-07-26 |
| Date Mfgr Received | 2001-08-28 |
| Device Manufacturer Date | 2001-04-01 |
| Date Added to Maude | 2001-10-02 |
| 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 | 2001-09-27 |
| Model Number | NA |
| Catalog Number | G0026 |
| Lot Number | A01099N1 |
| ID Number | NA |
| Device Expiration Date | 2003-03-01 |
| 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 | 342910 |
| 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. Other; 2. Required No Informationntervention | 2001-09-27 |