FDA Adverse Event
Injury
Summary report: N
KIN-COM 125E
MDR report key: 228921
·
Received June 25, 1999
Report
- Report Number
- 1022819-1999-00002
- Event Type
- Injury
- Date Received
- June 25, 1999
- Date of Event
- June 14, 1999
- Report Date
- June 23, 1999
- Manufacturer
- CHATTANOOGA GROUP, INC.
- Product Code
- IKK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICAL THERAPIST
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KIN-COM 125E | ISOKINETIC TESTING & EVAL SYSTEM | IKK | CHATTANOOGA GROUP, INC. | KIN-COM 125E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Hospitalization |