BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317080 |
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 08/03/2010 |
Event Type
Injury
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Event Description
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*note: this manufacturer report pertains to one of two devices implanted during the same procedure.Refer to manufacturer report number 3005099803-2023-03127 for solyx device.It was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during a sacrospinous vault suspension using uphold system + enterocele plication + solyx mid-urethral sling procedure performed on (b)(6) 2010, for the treatment of pelvic organ prolapse; stress urinary incontinence; and secondary diagnosis of cystocele and enterocele.The patient was taken to recovery in stable condition.As reported by the patient's attorney, the patient experienced an unknown injury.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6) 2010, 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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Search Alerts/Recalls
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