MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-15 for GLIOTECH GEL manufactured by .
[794886]
Severe neck rigidity. Patient admitted with severe lower back pain with muscle spasms bilaterally and fever 2 days post -or- for discectomy which included gliotech gel placement prior to closure. Patient placed on antibiotics, dexc (and morphine for pain, methasone iv) x48 hrs. Bacterial meningitis ruled out. Diagnosis of aseptic meningitis made pt admitted 09/24, discharged 09/28. Symptoms resolved without further intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005691 |
| MDR Report Key | 1003961 |
| Date Received | 2008-01-15 |
| Date of Report | 1999-01-15 |
| Date of Event | 1998-09-24 |
| Date Added to Maude | 2008-03-04 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLIOTECH GEL |
| Generic Name | NONE |
| Product Code | MLQ |
| Date Received | 2008-01-15 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 973471 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-15 |