MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-07-24 for ADCON-L ANTI-ADHESION BARRIER GEL G0001 manufactured by Gliatech Medical Inc..
[269596]
On 6/2002, a gliatech employee received a notice of claim from attorney pertaining to a product liability lawsuit for adcon-l. The letter accompanying the notice of claim stated that, "in 1999, a pt underwent spinal surgery to repair a disc herniation and lumbar stenosis at l4-5 at medial center. The surgery was "apparently uneventul. Adcon-l was applied to the surgical field. " the pt "developed increasing back pain. Pt was readmitted to medical center 18 days later with a tentative diagnosis of diskitis and was treated with iv antibiotics and iv pain medication. When pt did not improve, pt was returned to surgery where 'a copious amount of inflammatory material was excised... At the axilla of the l5 nerve root, extending down to the shoulder of the s1 nerve root'. On patholgoy examination, the excised material was identified as being fibrous and other tissue reactive to 'foreign material compatible with gelfoam'. " no additional info is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2002-00017 |
| MDR Report Key | 406991 |
| Report Source | 00 |
| Date Received | 2002-07-24 |
| Date of Report | 2002-07-24 |
| Date of Event | 1999-06-23 |
| Date Mfgr Received | 2002-06-26 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 2002-07-29 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 23420 COMMERCE PARK RD |
| 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 | 2002-07-24 |
| Model Number | NA |
| Catalog Number | G0001 |
| Lot Number | A9053N1 |
| ID Number | NA |
| Device Expiration Date | 2001-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 395982 |
| 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 | G0001 |
| Baseline ID | NA |
| 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. Hospitalization; 2. Required No Informationntervention | 2002-07-24 |