MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-06-25 for KIN-COM 125E 5150 manufactured by Chattanooga Group, Inc..
[126959]
Pt receiving therapy after hip surgery (pin placed to correct fracture) eight (8) weeks prior. Pt had been full weight bearing for four (4) weeks prior to therapy. Pt had completed one routine of exercises (120/60). On the third or fourth repetition of the next routine (150/75), the pt felt a sharp pain in the hip area. A fracture was found on x-ray below where the pin had been inserted. No malfunction was reported before, during or after the incident. The device is still in use at the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-1999-00002 |
| MDR Report Key | 228921 |
| Report Source | 06 |
| Date Received | 1999-06-25 |
| Date of Report | 1999-06-23 |
| Date of Event | 1999-06-14 |
| Date Mfgr Received | 1999-06-15 |
| Device Manufacturer Date | 1989-03-01 |
| Date Added to Maude | 1999-06-29 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIN-COM 125E |
| Generic Name | ISOKINETIC TESTING & EVAL SYSTEM |
| Product Code | IKK |
| Date Received | 1999-06-25 |
| Model Number | KIN-COM 125E |
| Catalog Number | 5150 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 222004 |
| Manufacturer | CHATTANOOGA GROUP, INC. |
| Manufacturer Address | 4717 ADAMS RD. HIXSON TN 37343 US |
| Baseline Brand Name | KIN-COM 125E |
| Baseline Generic Name | ISOKINETIC TESTING & EVAL SYSTEM |
| Baseline Model No | KIN-COM 125E |
| Baseline Catalog No | 5150 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1999-06-25 |