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 |