MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-05-15 for SHELHIGH DURASHIELD SHP-555-DS SHP-555-68-DS manufactured by Shelhigh, Inc..
[324846]
In 2003 this pt had brain surgery for malignant brain tumor. The dura was closed with durashield and a ventricular drainage catheter was placed. (could also be a source of contamination). One week post-op, the pt had cns symptoms and a lumbar puncture was performed to analyze their csf; was abnormal but found to be sterile. Subsequently the pt developed infection of the lumbar spine, and eventually grew aspergillus fumigatas. Although rare, this hospital infection could be related to the lumbar puncture or to the procedure. The device was obviously sterile. Also, if this was device related, the infection would be central and not distally to the place of implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247123-2003-00001 |
| MDR Report Key | 461053 |
| Date Received | 2003-05-15 |
| Date of Report | 2003-05-07 |
| Date of Event | 2003-03-10 |
| Date Facility Aware | 2003-04-21 |
| Report Date | 2003-05-07 |
| Date Reported to FDA | 2003-05-07 |
| Date Reported to Mfgr | 2003-04-21 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2003-05-22 |
| 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 | 3 |
| Manufacturer Contact | DR SHLOMO GABBAY,CHIEF SCIENTIFIC O |
| Manufacturer Street | 650 LIBERTY AVE |
| Manufacturer City | UNION NJ 07083 |
| Manufacturer Country | US |
| Manufacturer Postal | 07083 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHELHIGH DURASHIELD |
| Generic Name | PERICARDIAL PATCH USE TO REPLACE THE DURA |
| Product Code | MFX |
| Date Received | 2003-05-15 |
| Model Number | SHP-555-DS |
| Catalog Number | SHP-555-68-DS |
| Lot Number | 020324-NR |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 449995 |
| Manufacturer | SHELHIGH, INC. |
| Manufacturer Address | 650 LIBERTY AVE. UNION NJ 07083 US |
| Baseline Brand Name | SHELHIGH DURASHIELD |
| Baseline Generic Name | PERICARDIAL PATCH USE TO REPLACE THE DURA |
| Baseline Model No | SHP-555-DS |
| Baseline Catalog No | SHP-555-68-DS |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2003-05-15 |