MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2002-08-07 for ADCON-L ANTI-ADHESION BARRIER GEL G0001 manufactured by Gliatech Medical, Inc..
[290146]
In 7/02, gliatech, inc received a letter from customer, who reportedly had surgery in 2000 to correct a re-herniation of l5-s1; adcon-l was administered. Customer reported three days later, to have developed a spontaneous cerebral spinal fluid leak and readmission to the hosp. Customer was in the hosp for 6 days with severe spinal headaches, extreme discomfort, migraine headaches, nausea, vomiting, vertigo and lack of bowel and bladder control and was administered a pca morphine drip. Two shunts in the extreme ends of customer's spinal column drained 900-1100 cc's of spinal fluid. Customer reported that the initial l5-s1 surgery was performed in 2000, followed by the second surgery described above (2 mos later) and reports a third lumbar surgery in 2001 to loosen up scar tissue. Customer currently being evaluated for reconsideration of further spinal surgery. Customer is disabled and not able to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2002-00018 |
| MDR Report Key | 409656 |
| Report Source | 04 |
| Date Received | 2002-08-07 |
| Date of Report | 2002-08-07 |
| Date of Event | 2000-07-24 |
| Date Mfgr Received | 2002-07-12 |
| Device Manufacturer Date | 2000-02-01 |
| Date Added to Maude | 2002-08-13 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 23420 COMMERCE PARK RD |
| Manufacturer City | CLEVELAND OH 44122 |
| Manufacturer Country | US |
| Manufacturer Postal | 44122 |
| Manufacturer Phone | 2168313200 |
| Manufacturer G1 | EMCM |
| Manufacturer Street | MIDDENKAMPWEG 17 |
| Manufacturer City | NIJMEGEN 6545CH |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 6545 CH |
| 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 | 2002-08-07 |
| Model Number | NA |
| Catalog Number | G0001 |
| Lot Number | A0047N1 |
| 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 | 398669 |
| 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 | 2002-08-07 |