MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2004-05-20 for CATHETER PUDENZ PERITONEAL LOW PRESSURE STRIPE * NL850-1390 manufactured by Integra Neurosciences, Inc..
[19256036]
The user facility reported catheter was implanted on a pt with a programmable valve shunt (v-p shunt) system in 1996. Since the physician noticed that the catheter was torn in dec. 2003. The catheter was removed in 2003. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648988-2004-00020 |
| MDR Report Key | 563041 |
| Report Source | 01,08 |
| Date Received | 2004-05-20 |
| Date of Report | 2004-05-19 |
| Date Mfgr Received | 2004-04-20 |
| Date Added to Maude | 2005-01-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JENNA KARABAS |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08563 |
| Manufacturer Country | US |
| Manufacturer Postal | 08563 |
| Manufacturer Phone | 6099362236 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES, INC. |
| Manufacturer Street | STATE ROAD 402,KM 1.2 P.O. BOX 167 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER PUDENZ PERITONEAL LOW PRESSURE STRIPE |
| Generic Name | CSF PRODUCT |
| Product Code | GBW |
| Date Received | 2004-05-20 |
| Model Number | * |
| Catalog Number | NL850-1390 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 552765 |
| Manufacturer | INTEGRA NEUROSCIENCES, INC. |
| Manufacturer Address | * ANASCO PR * US |
| Baseline Brand Name | PUDENZ PERITONEAL CATHETER, LOW |
| Baseline Generic Name | PERITONEAL CATHETER |
| Baseline Model No | NL850-1390 |
| Baseline Catalog No | NL850-1390 |
| Baseline ID | NA |
| Baseline Device Family | PERITONEAL CATHETER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-20 |