Model Number 3219 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Pain (1994); Post Operative Wound Infection (2446)
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Event Date 11/07/2014 |
Event Type
Injury
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Event Description
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It was reported the patient went to the er as there was swelling pain and yellow, pus like drainage on her incision site on her back.She was prescribed antibiotics for 7 days and pain medication.Cultures were taken.Follow up information identified the patient was sent to the neurosurgeon because the incision site still appeared infected.The patient was prescribed a different antibiotic.
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Manufacturer Narrative
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(b)(4).Method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Follow up information identified the infection has resolved.
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Manufacturer Narrative
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Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Follow up information identified the product has been returned to the manufacture , however; it is unknown when the product was explanted.
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Manufacturer Narrative
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The returned product was not analyzed as the complaint of infection could not be confirmed via laboratory testing.
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Search Alerts/Recalls
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