MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-01 for KINCOM 500H manufactured by Chattanooga Group.
[7311]
Pt was on the exercise machine in outpatient therapy, (work hardening program), in the seated position with the lever arm in front of her chest. The lever arm moved unexpectedly and pushed the pt backward. Pt denied injury and did not wish to see physician. On 3/14/94 therapist called pt; pt reported increased soreness in back extension and was seen by md that day. On 3/21/94 pt had follow-up appointment. X-ray negative; missed one-half week of treatment but this did not jeopardize her program. Equipment was shut down immediately, co contacted and said relay in equipment was bad. Mfr sent person to repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001411 |
| MDR Report Key | 12500 |
| Date Received | 1994-04-01 |
| Date of Report | 1994-03-22 |
| Date of Event | 1994-03-11 |
| Date Added to Maude | 1994-04-04 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KINCOM |
| Generic Name | EXERCISE MACHINE |
| Product Code | IKK |
| Date Received | 1994-04-01 |
| Model Number | 500H |
| ID Number | CONTROL #SN-5261 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12500 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN 37343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-04-01 |