MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-09 for NEURO-TRACE NEEDLE 556-23-04 * manufactured by Hdc Corp..
[21611048]
"needles were blocked when medication was inserted. Doctor tried to re-start the procedure and needles were blocked. No injury reported or medical intervention was needed. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2925153-2005-00023 |
| MDR Report Key | 571419 |
| Report Source | 05 |
| Date Received | 2005-02-09 |
| Date of Report | 2005-02-08 |
| Date Added to Maude | 2005-02-10 |
| 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 | 3 |
| Manufacturer Street | 628 GIBRALTAR COURT |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal | 95035 |
| Manufacturer Phone | 4089427340 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURO-TRACE NEEDLE |
| Generic Name | NEURO-TRACE NEEDLE |
| Product Code | HAS |
| Date Received | 2005-02-09 |
| Model Number | 556-23-04 |
| Catalog Number | * |
| Lot Number | 0106 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 561270 |
| Manufacturer | HDC CORP. |
| Manufacturer Address | 628 GIBRALTAR CT. MILPITAS CA 95035 US |
| Baseline Brand Name | NEURO-TRACE NEEDLE |
| Baseline Generic Name | NEURO-TRACE NEEDLE |
| Baseline Model No | 556-23-04 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-09 |