BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 was used during a pelvic floor repair performed on (b)(6) 2017.According to the complainant, during deployment of the capio device, the needle detached from the suture.The detached piece was left inside the patient.The procedure was completed with a different device.There were no patient complications reported as a result of this event.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Search Alerts/Recalls
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