BOSTON SCIENTIFIC CORPORATION PFR KIT UPHOLD LITE VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317170 |
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 06/10/2013 |
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) 2013, 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 pfr kit uphold lite vaginal support system device was implanted into the patient during a bilateral sacrospinous fixation + anterior posterior colporrhaphy + transobturator suburethral sling + cystoscopy + insertion of mesh in 2 separate compartments procedure performed on (b)(6) 2013 for the treatment of stage 2 pelvic organ prolapse - marked cystocele, rectocele, vaginal vault prolapse.The patient tolerated the procedure well and was sent to the recovery room in stable satisfactory condition.As reported by the patient's attorney, the patient experienced an unknown injury.
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Search Alerts/Recalls
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