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 Problems
Erosion (1750); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123)
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Event Date 07/23/2012 |
Event Type
Injury
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Manufacturer Narrative
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Block b3: date of event was approximated to (b)(6) 2012, the implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006: erosion, e2330: pain, e1906: infection, e1401: discharge, e0506: bleeding.Imdrf impact code f1905 captures the reportable events of mesh removal.
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Event Description
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It was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during a procedure performed on (b)(6) 2012.As reported by the patient's attorney, the patient has suffered pain and severe infections, mesh erosion, bleeding and discharge, and additional medical treatment and procedures including removal.She also claimed to have suffered pain and suffering, and medical expenses as a result of the implantation.
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Search Alerts/Recalls
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