[581706]
Proudct description - hip abductor wedge foam wedge with one end that is wider than the other end, equipped with 2 sets of velcro straps, one set on the wider end and one set on the narrower end. Physician stated purpose of the device 1. Maintain abduction of my father's hip postoperative to the open surgical repair of a hip fracture. 2. Maintain abduction of my father's hip following closed reduction of 1st dislocation. 3. Maintain abduction during sleep and turning for an extended period due to parkinson disease. Problem 1. The foam hip abductor wedge with velcro straps had no instructions for use accompanying the device. 2. The wedge had no label with the mfr's name and contact info. 3. The wedge had no diagram on it to show clinical personnel how to position the device on the pt: - "top" and "bottom" were not indicated on the device. - where between legs - from the upper thigh to the knees or below- to position the wedge was not indicated on the wedge. Product use error confusion - we found that a lack of a diagram on the hip abductor wedge and a lack of instructions for use resulted in confusion over how to place the device on my father: 1. We found that it was unclear to clinical personnel whether to place the wide or the narrow end up. 2. We found that the clinical personnel were unsure and inconsistent with where between the legs from the upper thighs to the knees or below they should place the wedge. 3. Since hospital and skilled nursing personnel change with every shift, and without instructions for use on or with the device, the opportunity for error was multiplied. Adverse event without a diagram or other positioning instructions on or with the device. The wedge was positioned too low between my father's legs. When the velcro straps were then secured, the straps pulled my father's knee inward which adducted rather than abducted his hip. By the time the improper placement too low on my father's legs was discovered, my father's hip had dislocated again. Hospitalization prolonged, the decision was made to reoperate the hip in an open surgical procedure. Disability or permanent damage required intervention to prevent permanent impairment. Other serious - important medical events- postoperative delirum and dementia contributed to difficulty qualifying for rehabilitation; increasing immobility then led to a decubitis ulcer on the buttocks; and the complications increased as time passed. Following the second open hip surgery, due to my father's parkinson disease, my father's physician ordered the hip abductor wedge be used for several months when he was sleeping. This meant that the wedge would be placed on my father as many as three times a day. We asked the hosp and then the skilled nursing facility to post instructions and a diagram for use of the hip abduction wedge above my father's bed. They did. Nevertheless, the personnel were not used to looking for it and we had to regularly remind his frontline staff that the instructions were posted. We asked that the staff be inserviced and some members were but turnover and time constraints continued to lead to confusion by some staff over how to safely place the hip abductor wedge and secure the velcro straps. Device labeling request. My father's experience may have been very different if he had been able to avoid the second dislocation and reoperation. In my opinion, simple registration of foam hip abductor wedges is not enough. Since these devices are used in an acute care setting following open hip surgery, pts will be better served when these devices are required to be labeled. We were told that a private manufacturer/inventor distributed the device.
Patient Sequence No: 1, Text Type: D, B5