MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-10-03 for SHARPX NEEDLE DESTRUCTION UNIT NDU-1 * manufactured by Biomedical Disposal, Inc..
[169442]
Nurse placed their hand on counter next to sharpx. Thumb was pierced by sharp needle debris (partially destroyed needle).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1065528-2000-00002 |
| MDR Report Key | 298639 |
| Report Source | 05,06 |
| Date Received | 2000-10-03 |
| Date of Report | 2000-09-05 |
| Date of Event | 2000-08-31 |
| Date Facility Aware | 2000-09-05 |
| Report Date | 2000-09-05 |
| Date Reported to FDA | 2000-10-02 |
| Date Reported to Mfgr | 2000-09-05 |
| Date Mfgr Received | 2000-09-05 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2000-10-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RONALD FLOWER |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | 3009595 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARPX NEEDLE DESTRUCTION UNIT |
| Generic Name | NEEDLE DESTRUCTION UNIT |
| Product Code | MTV |
| Date Received | 2000-10-03 |
| Returned To Mfg | 2000-09-05 |
| Model Number | NDU-1 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 289075 |
| Manufacturer | BIOMEDICAL DISPOSAL, INC. |
| Manufacturer Address | 3690 HOLCOMB BRIDGE RD. NORCROSS GA 300922257 US |
| Baseline Brand Name | SHARPX NEEDLE DESTRUCTION UNIT |
| Baseline Generic Name | NEEDLE DESTRUCTION UNIT |
| Baseline Model No | NDU-1 |
| Baseline Catalog No | NA |
| Baseline Device Family | NDU |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P9800 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-03 |