MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,08 report with the FDA on 2001-08-03 for SYSTEM 3 830-200 manufactured by Biodex Medical Systems, Inc..
[244113]
The concerned person has been attended in the continuous passive motion of the biodex pro 3. The person was very disquietingly and tinkered with the device. The concerned person's left trigger finger intervened between the adapter and the motion mechanical stop of the dynamometer head of the biodex. The concerned person's finger has been swatted and concerned person had to be attended in the ambulance of the hospital. Diagnosis: rip wound on the left finger with partial amputation, left trigger finger, efiphysoloyse of the terminal link.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431314-2001-00001 |
| MDR Report Key | 345682 |
| Report Source | 00,01,08 |
| Date Received | 2001-08-03 |
| Date of Report | 2001-08-03 |
| Date of Event | 2001-06-28 |
| Date Mfgr Received | 2001-07-09 |
| Device Manufacturer Date | 1998-02-01 |
| Date Added to Maude | 2001-08-08 |
| 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 | CLYDE SCHLEIN |
| Manufacturer Street | 20 RAMSAY ROAD P.O. BOX 702 |
| Manufacturer City | SHIRLEY NY 11967 |
| Manufacturer Country | US |
| Manufacturer Postal | 11967 |
| Manufacturer Phone | 6319249000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 3 |
| Generic Name | MULTI-JOINT TEST & REHAB DEVICE |
| Product Code | ISD |
| Date Received | 2001-08-03 |
| Model Number | SYSTEM 3 |
| Catalog Number | 830-200 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 335015 |
| Manufacturer | BIODEX MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 20 RAMSAY ROAD P.O. BOX 702 SHIRLEY NY 11967 US |
| Baseline Brand Name | SYSTEM 3 |
| Baseline Generic Name | MULTI-JOINT TEST & REHAB DEVICE |
| Baseline Model No | SYSTEM 3 |
| Baseline Catalog No | 830-200 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2001-08-03 |