MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-09-25 for KIN-COM II 5030 manufactured by Chattanooga Group, Inc..
[17033603]
Employee at physical therapy clinic wanted to experience an eccentric contraction on kin-com dynamometer. During exercise, her patella dislocated. Patella was reset immediately. Device was operating within its normal operating parameters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-1998-00001 |
| MDR Report Key | 189232 |
| Report Source | 06 |
| Date Received | 1998-09-25 |
| Date of Report | 1998-09-24 |
| Date of Event | 1998-01-23 |
| Date Mfgr Received | 1998-01-26 |
| Device Manufacturer Date | 1986-06-01 |
| Date Added to Maude | 1998-09-29 |
| 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 |
| Reporter Occupation | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIN-COM II |
| Generic Name | ISOKINETIC TESTING & EVALUATION SYSTEM |
| Product Code | IKK |
| Date Received | 1998-09-25 |
| Model Number | 5030 |
| Catalog Number | 5030 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 183898 |
| Manufacturer | CHATTANOOGA GROUP, INC. |
| Manufacturer Address | 4717 ADAMS RD HIXSON TN 37343 US |
| Baseline Brand Name | KIN-COM II |
| Baseline Generic Name | ISOKINETIC TESTING & EVALUATION SYSTEM |
| Baseline Model No | 5030 |
| Baseline Catalog No | 5030 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-09-25 |