BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior repair with uphold lite mesh procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the dart detached from the suture.Reportedly, the detached dart could not be located and was not found in the capio device when it was checked, so the facility assumed that the dart was in the patient.
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Search Alerts/Recalls
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