Model Number KSC01465E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Insufficient Information (4580)
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Event Date 03/19/2022 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Mulitple mdrs were submitted for this adverse event: 3013450937-2022-00135, 3013450937-2022-00137, 3013450937-2022-00138, 3013450937-2022-00139, 3013450937-2022-00140 and 3013450937-2022-00141.
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Event Description
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On (b)(6) 2022 the patient received a superficial wound debridement to treat a superficial suture and sub-q abscess that developed after receiving distal femoral replacement surgery.
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Manufacturer Narrative
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This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the alleged infection could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4117: device not accessible for testing.H6: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.
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Event Description
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On (b)(6) 2022 the patient received a superficial wound debridement to treat a superficial suture and sub-q abscess that developed after receiving distal femoral replacement surgery.
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Search Alerts/Recalls
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