MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-02 for ACCU-EDGE MICROTOME BLAADE DISPENSER M7321-41 DIST NO manufactured by Miles Diagnostics.
[9169]
Safety supervisor explained that a technician trainee was putting a new blade in when her finger slidee over the dispenser knob and then over the edge of the blade. The injury required three stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1910735-1994-00011 |
| MDR Report Key | 14081 |
| Date Received | 1994-05-02 |
| Date of Report | 1994-04-26 |
| Date Facility Aware | 1994-04-05 |
| Report Date | 1994-04-26 |
| Date Reported to FDA | 1994-04-26 |
| Date Reported to Mfgr | 1994-04-07 |
| Date Added to Maude | 1994-06-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-EDGE MICROTOME BLAADE DISPENSER |
| Generic Name | MICROTOME ACCESSORY |
| Product Code | IDL |
| Date Received | 1994-05-02 |
| Model Number | NA |
| Catalog Number | M7321-41 DIST NO |
| Lot Number | UNKNOWN |
| ID Number | 4689-MILES MFG. NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14078 |
| Manufacturer | MILES DIAGNOSTICS |
| Manufacturer Address | 1127 MYRTLE STREET ELLKHART IN 465153100 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-05-02 |