MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-04-26 for ADCON-L ANTI-ADHESION BARRIER GEL G0026 manufactured by Gliatech Medical Inc..
[21250542]
In 2002, gliatech received a letter from the ra/qa rep at distributor stating that a "few weeks ago" she had a conversation with hosp. During the conversation, hosp requested the address for allergy diagnostic (a testing facility which performs anti-gelatin ige tests) so that she could, "send a blood sample from a pt who showing a symptoms of hypotension following application of adcon-l". Per the ra/qa rep, at that time, hosp did not wish to file a complaint. Distributor then sent a letter requesting info and they received a return letter from hosp. In the letter hosp stated, "i spoke with dr regarding my inquiry: the pt concerned was operated in the private sector and not their hosp. Dr has informed me that all the test results were negative and was not an immediate reaction but occurred several hours later, and was not related to adcon-l". No further details are available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2002-00011 |
| MDR Report Key | 390459 |
| Report Source | 05 |
| Date Received | 2002-04-26 |
| Date of Report | 2002-04-26 |
| Date Mfgr Received | 2002-03-28 |
| Date Added to Maude | 2002-04-30 |
| 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 | 3 |
| 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 | 2002-04-26 |
| 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 | 379508 |
| 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. Life Threatening | 2002-04-26 |