MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-04-10 for ADCON-L ANTI-ADHESION BARRIER GEL G0026 manufactured by Gliatech Medical, Inc..
[18949527]
In 2002, gliatech's distributor in the uk (forth medical) described a conversation with consultant plastic surgeon in which he notes that he had observed occasional "raging infections" following application of adcon for tenolysis procedures. Per the distributor, the surgeon believes that "the presence of adcon seems to exacerbate the infective episode. Upon further clarification, it was determined that the infections occurred following application of adcon-t/n (not commercially available in the united states). The surgeon recalled that he had observed approximately five total cases of infection. Although these infections initially appeared to involve adcon-t/n, the surgeon did state that one recent case of infection (approximately three weeks ago) occurred following an off label use of adcon-l. In all cases the surgeon reported that the infections developed within twenty-four hours of the surgical procedure. Surgeon described the infections as "a bag of puss surrounding the wound". All pts are presently doing well following administration of antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2002-00009 |
| MDR Report Key | 387560 |
| Report Source | 05 |
| Date Received | 2002-04-10 |
| Date of Report | 2002-04-05 |
| Date Mfgr Received | 2002-03-08 |
| Date Added to Maude | 2002-04-12 |
| 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 | 2002-04-10 |
| 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 | 376588 |
| 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 | 2002-04-10 |