DSM BIOMEDICAL XCM BIOLOGIC TISSUE MATRIX; MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS
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Device Problem
Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/14/2015 |
Event Type
Injury
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Manufacturer Narrative
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The mesh tears were repaired during the planned second stage procedure.Therefore, the device remains in the patient and will not be returned for evaluation.No photographs of the device have been provided for evaluation.No model number and lot number have been provided.Therefore, no device evaluation or manufacturing record review could be performed.In addition, no information has been provided about the patient's demographics, method of mesh implantation or concomitant medical products used.Multiple attempts have been made to obtain additional clinical information.If additional information is provided, it will be reported in a follow-up mdr.
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Event Description
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It was reported that xcm biologic was implanted in a patient as part of a complex, multi-stage abdominal surgical procedure that involved colon resection and repair of multiple fistulas.At the end of the procedure, the surgical wound was left open due to the complexity of the case and wound closure was planned for the following day.During the second stage of the procedure, the surgeon observed 'some small tears' in the mesh.The tears were repaired during the second stage procedure and the surgical wound was closed.No clinical consequences were observed.
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