MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2008-08-08 for COMPLETE TUNNELING KIT NL950-VC manufactured by Integra Neurosciences.
[21990371]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[22121498]
The distributor reports on behalf of the user facility. The device displayed an error reading code e09. After this error message was displayed, it was decided by the facility to remove the device and insert a new one. The new device worked perfectly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023988-2008-00027 |
| MDR Report Key | 1105847 |
| Report Source | 01,05,08 |
| Date Received | 2008-08-08 |
| Date of Report | 2008-08-08 |
| Date Mfgr Received | 2008-07-25 |
| Date Added to Maude | 2010-04-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARION GREEN, RN |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362469 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES |
| Manufacturer Street | 5955 PACIFIC CENTER BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPLETE TUNNELING KIT |
| Generic Name | ICP DISPOSABLES |
| Product Code | HCA |
| Date Received | 2008-08-08 |
| Catalog Number | NL950-VC |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-08 |