Model Number 3166 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Tissue Breakdown (2681)
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Event Date 06/08/2018 |
Event Type
Injury
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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.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 2 of 4.Reference mfr.Report: 1627487-2018-05911, reference mfr.Report: 1627487-2018-05913, reference mfr.Report: 1627487-2018-05914.It was reported the patient experienced an area on the left temple that opened and has a scab.The patient¿s target pain pattern has decreased since having a hysterectomy, and the patient is requesting the scs system to be explanted.The physician prescribed antibiotics for the scabbed left temple, and the patient may be awaiting scs system explant as the next course of action.
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Event Description
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Device 2 of 4: reference mfr.Report: 1627487-2018-05911; reference mfr.Report: 1627487-2018-05913; reference mfr.Report: 1627487-2018-05914.Follow up information identified the patient¿s scabbing has improved.
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Event Description
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Device 2 of 4: reference mfr.Report: 1627487-2018-05911, reference mfr.Report: 1627487-2018-05913, reference mfr.Report: 1627487-2018-05914.Follow up information identified the patient¿s same scabbed area on her left temple has re-opened.The patient is undecided on the next course of action.
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Search Alerts/Recalls
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