Model Number 3346 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Impaired Healing (2378)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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.(b)(4).
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Event Description
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Device 3 of 3: reference mfr report: 1627487-2017-00532 & 3006705815-2017-00095.It was reported that the patient has experienced oozing at the ipg and extension site.Patient has declined to see a wound care specialist, but is on prophylactic antibiotics.
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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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Device 3 of 3: reference mfr report: 1627487-2017-00532 & 3006705815-2017-00095.Follow-up revealed that the patient's condition complicated further.In addition, on (b)(6) 2017 the patient's physician opened both incision sites and cleaned them with betadine.Patient's condition seems to have improved.
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Event Description
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Device 3 of 3.Reference mfr report: 1627487-2017-00532 & 3006705815-2017-00095.Follow-up revealed that the issue has been resolved.
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.
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Event Description
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Device 3 of 3.Reference mfr report: 1627487-2017-00532 & 3006705815-2017-00095.Follow-up revealed that the patient's wound reopened and showed signs of infection.As a result, the patient underwent surgical intervention on (b)(6) 2017 to have their scs system explanted.
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Event Description
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Device 3 of 3.Reference mfr report: 1627487-2017-00532 & 3006705815-2017-00095.Follow up revealed that the infection has cleared up.
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Search Alerts/Recalls
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