MAUDE MDR 461053
- MDR report key
- 461053
- Report number
- 2247123-2003-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-03-10
- Date received
- 2003-05-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact
- Contact
- DR SHLOMO GABBAY,CHIEF SCIENTIFIC O
- Address
- 650 LIBERTY AVE UNION NJ 07083 US
- Phone
- *
- Report source
- M
- Manufacturer link flag
- Y
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | SHELHIGH DURASHIELD | PERICARDIAL PATCH USE TO REPLACE THE DURA | SHELHIGH, INC. | MFX | SHP-555-DS | SHP-555-68-DS | 020324-NR | | | N | R | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2003-05-15 | 0 | 1. H; 2. L; 3. R; 4. S
|
Event Narratives
D
Patient 1
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.
Related GUDID Devices By Product Code
No records found.
Related PMN/PMA Records By Product Code
| Type | Submission | Product code | Device | Applicant | Decision date |
|---|
| 510(k) | K061727 | MFX | GORE PRECLUDE VESSEL GUARD | W. L. Gore & Associates, Inc. | 2006-08-07 |
| 510(k) | K960532 | MFX | PRECLUDE IMA SLEEVE | W. L. Gore & Associates, Inc. | 1996-05-23 |