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
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/31/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Mfg.Site name - freudenberg medical.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an uphold¿ lite device was used during a placement of uphold procedure performed on (b)(6) 2017.According to the complainant, during the procedure, upon deployment, the needle detached from the suture.The detached part was removed from the patient through sterile clamps.The procedure was completed with another uphold¿ lite device.There were no reported patient complications as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.Note: this report pertains to one of two devices used during the same procedure.Associated mfr.Report #3005099803-2017-02803 pertains to the other device.
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Search Alerts/Recalls
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