MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-10 for B.C.M. BCM-MS-600 manufactured by B.c. Medical.
[21695761]
User may have overridden door interlock sensor while cycling the machine, resulting in fracture to the distal area of the user's right ring finger which waas replaced in a mechanism containing moving parts. Note: useer was specifically notified of correct/safe operating procedures during a prior service call.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020563-1993-00014 |
| MDR Report Key | 16458 |
| Date Received | 1994-01-10 |
| Date of Report | 1993-11-09 |
| Date of Event | 1993-11-02 |
| Date Facility Aware | 1993-11-03 |
| Report Date | 1993-11-09 |
| Date Reported to FDA | 1993-11-10 |
| Date Reported to Mfgr | 1993-11-10 |
| Date Added to Maude | 1994-09-28 |
| 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 | B.C.M. |
| Generic Name | FILM CHANGER - CUT FILM |
| Product Code | IZP |
| Date Received | 1994-01-10 |
| Model Number | BCM-MS-600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16391 |
| Manufacturer | B.C. MEDICAL |
| Manufacturer Address | 3655 RICHELIEU STREET MONTREAL QUEBEC CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-01-10 |