MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-02-07 for ADCON-L UNK manufactured by Gliatech.
[314950]
Pt received adcon-el into epidural space. Pt felt device was used without proper consent. Pt felt they were improperly informed of the substance that was injected. Pt stated that they felt intense pain after injection with subsequent paralysis. Pt stated that md encountered resistance when injecting the device, but continued to force the substance into epidural space. Now continues with extreme pain, staph infections, sepsis. Epidural abscess - nov. 2002. Mrsa - hospitalized due to problems related to device, cystitis, osteomylitis. Intractable pain. Osteomylitis in every disc from l, all the way down, unable to ambulate.
Patient Sequence No: 1, Text Type: D, B5
[315904]
Add'l info received from patient on 2/24/03: since then, they have had numerous complications including mrsa infection, prolonged hospital stay, weight gain & phychosis (from steroids), and foot & hand drop. Caller states they "almost died".
Patient Sequence No: 1, Text Type: D, B5
[344063]
Add'l info rec'd from rptr 11/05/04: pt was injected with biological adhesion with aluminum in the lot. Pt has alzheimer's disease now with no prior history of alzheimers. Dr sent pt home semi-paralyzed. Pt action are inappropriate, poor short term memory. Had i. Q. Of 166 and can never practice medicare again, correct medication is aricept which has improved memory somehow. Pt is completely paralyzed all the way down with physical pain threshold pt wants all other pts on that lot no to be notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1027468 |
| MDR Report Key | 441939 |
| Date Received | 2003-02-07 |
| Date of Report | 2003-02-07 |
| Date of Event | 1999-10-28 |
| Date Added to Maude | 2003-02-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADCON-L |
| Generic Name | ADHESION BARRIER |
| Product Code | MLQ |
| Date Received | 2003-02-07 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 430915 |
| Manufacturer | GLIATECH |
| Manufacturer Address | 23420 COMMERCE PARK ROAD CLEVELAND OH 44122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-02-07 |