BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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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 11/15/2018 |
Event Type
Injury
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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 during an anterior colporrhaphy, solyx sling and cystoscopy procedure performed on (b)(6) 2018, for the treatment of cystocele and stress urinary incontinence.Throughout the procedure, there were no complications.Furthermore, the patient was taken to recovery room in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to november 15, 2018, implant date, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: imdrf patient code e2401 captures the reportable event of an unspecified personal injury.Impact code f12 has been used in the light of the patient seeking legal recourse for an unspecified personal injury related to the device.
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Search Alerts/Recalls
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