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Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 12/28/2016 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Patient presents with intense pain in both legs, more on the right than the left.Sharp, shooting sensations everytime he walks or puts pressure on his foot.The case report form indicates the event is definitely not related to devices and definitely not related to procedure.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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Upon review of this event, it is found not to meet the definition of a complaint, as there is no alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.There is no reasonable causality between the device in the left hip to the pain the patient experienced in the right leg.Purposed date of surgery as noted from database (b)(6) 2016.
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Event Description
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It was reported that a patient stated that he was having intense pain in both legs, more so on the right than the left.He was having sharp shooting sensation every time he walks or put pressure on the foot.Patient states this started early in the morning.He states his right leg is swollen and slightly red, notice veins bulging.Patient was advised to ice and elevate for 2-3 hours and avoid doing any activities, nurse will call the hospital to have a nurse rule out dvt.Patient presented to the er, then admitted for observation.Admitted for less than 24 hours.Associated mfrs: 1038671-2017-00004, 1038671-2017-00005, 1038671-2017-00006, 1038671-2017-00007, and 1038671-2017-00008.
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Search Alerts/Recalls
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