MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-03-15 for ADJUSTABLE AUTOMATIC DONOR SCALE 4R4419 manufactured by Highland Laboratories.
[192989]
The center reported that a staff nurse was cleaning up at the end of a site collection. Nurse backed up into a sharp metal tab on the automatic donor scale. It tore through the uniform and punctured her right calf leaving a wound and contusion. The nurse was treated for the wound and is getting baseline blood tests. There was no blood exposure to anyone else.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036337-2000-00001 |
| MDR Report Key | 270611 |
| Report Source | 05 |
| Date Received | 2000-03-15 |
| Date of Report | 2000-03-09 |
| Date of Event | 2000-02-17 |
| Date Mfgr Received | 2000-02-21 |
| Date Added to Maude | 2000-03-27 |
| 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 | 0 |
| Manufacturer Contact | DIANE MATTUCCI |
| Manufacturer Street | 1627 LAKE COOK RD. BUILDING LCIV-2 |
| Manufacturer City | DEERFIELD IL 60015 |
| Manufacturer Country | US |
| Manufacturer Postal | 60015 |
| Manufacturer Phone | 8479405975 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADJUSTABLE AUTOMATIC DONOR SCALE |
| Generic Name | ADJUSTABLE AUTOMATIC DONOR SCALE |
| Product Code | KSQ |
| Date Received | 2000-03-15 |
| Model Number | NA |
| Catalog Number | 4R4419 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 261975 |
| Manufacturer | HIGHLAND LABORATORIES |
| Manufacturer Address | 159 CHESTNUT ST ASHLAND MA 01721 US |
| Baseline Brand Name | ADJUSTABLE AUTOMATIC DONOR SCALE |
| Baseline Generic Name | DONOR SCALE |
| Baseline Model No | 4R4419 |
| Baseline Catalog No | 4R4419 |
| Baseline ID | NA |
| Baseline Device Family | ANCILLARY EQUIPMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-03-15 |