MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-01-31 for * manufactured by Lifenet.
[18147034]
Pt underwent a suboccipital craniectomy and c1 laminectomy with dural patch graft in 2003. Pt was discharged six days later. Pt returned to e. D. The next day with complaint of worsened headache and fever. Readmitted post-op meningitis. Returned to or two days later. Revision of suboccipital craniectomy for i&o with placement of evd catheter. Dural graft removed at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1124603-2005-00002 |
| MDR Report Key | 568777 |
| Report Source | 05 |
| Date Received | 2005-01-31 |
| Date of Report | 2005-01-26 |
| Date of Event | 2003-07-10 |
| Device Manufacturer Date | 2003-02-01 |
| Date Added to Maude | 2005-02-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID KLEMENTOWSKI |
| Manufacturer Street | 5809 WARD COURT |
| Manufacturer City | VIRGINIA BEACH VA 23455 |
| Manufacturer Country | US |
| Manufacturer Postal | 23455 |
| Manufacturer Phone | 7572274552 |
| Manufacturer G1 | LIFENET |
| Manufacturer Street | 5809 WARD COURT |
| Manufacturer City | VIRGINIA BEACH VA 23455 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23455 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | PERICARDIUM GRAFT |
| Product Code | LMO |
| Date Received | 2005-01-31 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 02-3636-016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 558606 |
| Manufacturer | LIFENET |
| Manufacturer Address | * VIRGINIA BEACH VA * US |
| Baseline Brand Name | * |
| Baseline Generic Name | PERICARDIUM GRAFT |
| Baseline Model No | NA |
| Baseline Catalog No | NA |
| Baseline ID | 02-3636-016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2005-01-31 |