BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507000 |
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 05/15/2019 |
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) 2019, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (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 solyx sis system device was implanted into the patient during an anterior colporrhaphy + solyx sling with cystoscopy + posterior colporrhaphy procedure performed on (b)(6) 2019, for the treatment of symptomatic cystocele, stress urinary incontinence and symptomatic rectocele.The patient was extubated in the operating room and transported to the recovery room in stable condition having tolerated the procedure well.As reported by the patient's attorney, the patient experienced an unknown injury.
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Search Alerts/Recalls
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