BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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 was used during a anterior vaginal repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the suture broke and detached with the needle outside the patient.The procedure was completed with another uphold lite.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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Search Alerts/Recalls
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