STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø12X400 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 1825-1240S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Headache (1880); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Swelling/ Edema (4577)
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Event Date 06/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Upon completion of the investigation any additional information will be communicated in a supplemental report.Device remains implanted.
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Event Description
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The customer (b)(6) reported to (b)(6) that: "right leg swollen, hard to the touch.Remains swollen for several hours after observation, until lying down, even though the leg was left in the open air without restraint (no socks or tight clothes).Shortness of breath and feeling of tiredness, headaches (occipital lobe area and frontal lobe area), very slight prickling sensation in the heart.The swollen legs, i observed them from (b)(6) 2006 to (b)(6) 2021, that's what made me decide to fill in these fields.".
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Event Description
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The customer "gd" reported to ansm that: "right leg swollen, hard to the touch.Remains swollen for several hours after observation, until lying down, even though the leg was left in the open air without restraint (no socks or tight clothes).Shortness of breath and feeling of tiredness, headaches (occipital lobe area and frontal lobe area), very slight prickling sensation in the heart.The swollen legs, i observed them from on (b)(6) 2021, that's what made me decide to fill in these fields.".
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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Search Alerts/Recalls
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