BOSTON SCIENTIFIC - MARLBOROUGH ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502110 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device is disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was used on an unknown procedure and date.According to the complainant, during unpacking, the staff member noticed that the outside box was damaged.The physician was uncertain if the product was still sterile so another sling was used for the case.There were no patient complications reported as a result of this event.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Search Alerts/Recalls
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