MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-10-06 for * 940-200 manufactured by Biodex Medical Systems, Inc.
[1116585]
The patient was in out-patient rehab completing an exercise on a cable column. The cable support ring that covered the link between the cable and the patient handle broke and exposed a metal edge. The patient received a skin tear from the exposed barb. The area was cleaned with alcohol. Bandaid and pressure applied.
Patient Sequence No: 1, Text Type: D, B5
[1328148]
The patient was in out-patient rehab completing an exercise on a cable column. The cable support ring that covered the link between the cable and the patient handle broke and exposed a metal edge. The patient received a skin tear from the exposed barb. The area was cleaned with alcohol. Bandaid and pressure applied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1515285 |
| MDR Report Key | 1515285 |
| Date Received | 2009-10-06 |
| Date of Report | 2009-10-06 |
| Date of Event | 2009-09-30 |
| Report Date | 2009-10-06 |
| Date Reported to FDA | 2009-10-06 |
| Date Added to Maude | 2009-10-26 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | * |
| Generic Name | SYSTEM, ISOKINETIC TESTING AND EVALUATION |
| Product Code | IKK |
| Date Received | 2009-10-06 |
| Model Number | 940-200 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIODEX MEDICAL SYSTEMS, INC |
| Manufacturer Address | 20 RAMSAY ROAD SHIRLEY NY 11967 US 11967 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-06 |