BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/02/2008 |
Event Type
Injury
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6) 2008, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: imdrf patient code e2401 captures the reportable event of unspecified injury.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.
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Event Description
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It was reported to boston scientific corporation that a pinnacle pelvic floor repair kits was implanted into the patient during a procedure performed on (b)(6) 2008.As reported by the patient's attorney, the patient experienced an unknown injury.
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Search Alerts/Recalls
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