MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-12-15 for PERIT R/C CATHETER STRIPED * NL850-1375 manufactured by Integra Neurosciences Pr, Inc..
[423672]
Prior to implantation, the user facility observed 2 of the 3 slits on the tip of the catheter were not completely open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648988-2005-00041 |
| MDR Report Key | 654376 |
| Report Source | 08 |
| Date Received | 2005-12-15 |
| Date of Report | 2005-12-14 |
| Date Mfgr Received | 2005-11-23 |
| Date Added to Maude | 2005-12-21 |
| 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 | YANGPING WANG |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362322 |
| 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 | PERIT R/C CATHETER STRIPED |
| Generic Name | CSF PRODUCTS |
| Product Code | GBW |
| Date Received | 2005-12-15 |
| Returned To Mfg | 2006-01-17 |
| Model Number | * |
| Catalog Number | NL850-1375 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 643852 |
| Manufacturer | INTEGRA NEUROSCIENCES PR, INC. |
| Manufacturer Address | * ANASCO PR * US |
| Baseline Brand Name | PERITONEAL REFLUX CONTROL CATHETER |
| Baseline Generic Name | PERITONEAL CATHETER |
| Baseline Model No | NL850-1375 |
| Baseline Catalog No | NL850-1375 |
| Baseline ID | * |
| Baseline Device Family | PERITONEAL CATHETER |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NI |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-15 |