MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-23 for EXERCISER manufactured by Cybex.
[11480]
Pt was performing exercise on the machine as per previous sessions when resistance gave way while performing 120 degrees/sec 8th repetition of 1st set.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 20720 |
| MDR Report Key | 20720 |
| Date Received | 1995-02-23 |
| Date of Report | 1995-02-20 |
| Date of Event | 1995-02-13 |
| Date Facility Aware | 1995-02-14 |
| Report Date | 1995-02-20 |
| Date Reported to FDA | 1995-02-22 |
| Date Reported to Mfgr | 1995-02-22 |
| Date Added to Maude | 1995-03-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | EXERCISER |
| Generic Name | EXERCISER |
| Product Code | ISD |
| Date Received | 1995-02-23 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 20605 |
| Manufacturer | CYBEX |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-02-23 |