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 09/01/2021 |
Event Type
Injury
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Event Description
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It was reported that an uphold vaginal support system device was implanted during a procedure performed on (b)(6) 2021.Due to the implantation, the patient experienced injuries including pain, severe infections, mesh erosion, bleeding and discharge.She also underwent additional medical treatment and procedures including removal.
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Manufacturer Narrative
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Block h6: imdrf patient codes e2330, e1401, e2006 and e1906 capture the reported events of pain, discharge, mesh erosion, and severe infection, respectively.Imdrf impact code f23 and f1905 capture the reported event of additional medical treatment and mesh removal.
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Manufacturer Narrative
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Block h2: correction block g3 (date received by manufacturer) has been updated to the correct manufacturer awareness date for this event, march 11, 2024.Block h6: imdrf patient codes e2330, e1401, e2006 and e1906 capture the reported events of pain, discharge, mesh erosion, and severe infection, respectively.Imdrf impact code f23 and f1905 capture the reported event of additional medical treatment and mesh removal.
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Event Description
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It was reported that an uphold vaginal support system device was implanted during a procedure performed on (b)(6) 2021.Due to the implantation, the patient experienced injuries including pain, severe infections, mesh erosion, bleeding and discharge.She also underwent additional medical treatment and procedures including removal.
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Search Alerts/Recalls
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