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 02/13/2019 |
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.Blocks 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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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted during a robotic total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, sacral colpopexy, solyx sling, cystocopy procedure performed on (b)(6) 2019.Throughout the procedure, there were no complications.Furthermore, the patient was transferred to the recovery room in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury.
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Search Alerts/Recalls
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