Catalog Number 211H6032 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Syncope (1610); Anemia (1706); Chest Pain (1776); Hemothorax (1896); Pain (1994); Pleural Effusion (2010); Syncope/Fainting (4411); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device product code: qhp.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports: 3012447612-2020-00544 to 3012447612-2020-00564.
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Event Description
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It was reported that a patient was admitted to the hospital, 2 weeks after undergoing a tether procedure, after presenting with increased pain on his right side.A ct was performed which revealed a hemothorax, a drain was placed with no immediate plans to return to the operating room.The patient was reported to have been discharged from the hospital but no further information was provided.This is report fourteen of twenty-one for this event.
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Event Description
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It was reported that a patient was admitted to the hospital, 2 weeks after undergoing a tether procedure, after presenting with increased pain on his right side.A ct was performed which revealed a hemothorax, a drain was placed with no immediate plans to return to the operating room.The patient was reported to have been discharged from the hospital but no further information was provided.Additional information was provided stating that the patient first presented to the er with shortness of breath, chest pain, and a single syncopal episode.He was released, returned after a clinical visit and was admitted to the hospital where an x-ray showed a large plueral effusion with atelectasis and a significant decrease in hemoglobin.The patient is reported to have been discharged and is in stable condition.This is report fourteen of twenty-one for this event.
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Manufacturer Narrative
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Device evaluation: product was not returned and photos were not provided, so device evaluation could not be performed.Potential cause root cause was unable to be determined.This event could possibly be attributed to surgical approach or unknown patient or operational factors.Dhr review per the dhr review, the part was likely conforming when it left zimmer biomet control.Device use these devices are used for treatment.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that a patient was admitted to the hospital, 2 weeks after undergoing a tether procedure, after presenting with increased pain on his right side.A ct was performed which revealed a hemothorax, a drain was placed with no immediate plans to return to the operating room.The patient was reported to have been discharged from the hospital but no further information was provided.Additional information was provided stating that the patient first presented to the er with shortness of breath, chest pain, and a single syncopal episode.He was released, returned after a clinical visit and was admitted to the hospital where an x-ray showed a large pleural effusion with atelectasis and a significant decrease in hemoglobin.The patient is reported to have been discharged and is in stable condition.This is report fourteen of twenty-one for this event.
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Search Alerts/Recalls
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