MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-02-24 for DYNATRON T3 TABLE T3GY manufactured by Dynatronics.
[1283897]
Patient prone on treatment table, arms dangling over the side of the table. Table at waist height. Upon lowering the table, patient's 4th digit on right hand was caught between the table's upper and lower frames. He yelled and the operator reversed the table direction immediately. Skin was broken on both ventral and dorsal aspects of the finger but the patient was able to flex and extend the distal phalanx.
Patient Sequence No: 1, Text Type: D, B5
[8443243]
Sales representative for dynatronics ((b)(4)) visited the clinic on (b)(4) 2010 to follow up on information received about a patient injury involving dynatron t3 hi-low table. Pt involved with the incident was not available for interview. The office receptionist confirmed the details of the incident as previously reported. Visual inspection of the table was made. No problems were noted with operation of table was made. No problems were noted with operation of table by the staff at clinic. Details of the incident as related to the operation of the device are as follows: patient was lying prone on table with hands hanging between upper frame assembly ((b)(4)) and base skirt ((b)(4)). As upper frame assembly lowers it passes through a slot on the base skirt ((b)(4)). Patient's right hand (fourth digit) was located below a screw on tube top pivot ((b)(4)). When pt lowered the table, patient's finger was caught between table's tube pivot and the slot on base skirt. Patient's finger was lacerated. Patient was seen at an urgent care facility where he received stitches, x-rays, and wound dressing. Ifu for t3 table clearly states on page 5 in treatment warnings and precautions section item #3, to advise patient prior to making any adjustments to table while patient is positioned on the table. Furthermore, item #4 of this section states: never place hands or feet near moving mechanisms while raising or lowering table. It is the expectation of manufacturer that the end user reads ifu and follows the instructions provided concerning warnings and precautions for operation of device. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719362-2010-00001 |
| MDR Report Key | 1617360 |
| Report Source | 06 |
| Date Received | 2010-02-24 |
| Date of Report | 2010-01-29 |
| Date of Event | 2010-01-27 |
| Date Mfgr Received | 2010-01-29 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2011-10-03 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCE FOGER |
| Manufacturer Street | 7030 PARK CENTRE DR. |
| Manufacturer City | COTTONWOOD HEIGHTS UT 84121 |
| Manufacturer Country | US |
| Manufacturer Postal | 84121 |
| Manufacturer Phone | 8008746251 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNATRON T3 TABLE |
| Generic Name | THREE SECTIONAL HI-LO TREATMENT TABLE |
| Product Code | INQ |
| Date Received | 2010-02-24 |
| Model Number | DYNATRON T3 |
| Catalog Number | T3GY |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYNATRONICS |
| Manufacturer Address | COTTONWOOD HEIGHTS UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-02-24 |