BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device 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 that an uphold (tm) lite with capio slim device was used during an anterior repair procedure on (b)(6) 2016.According to the complainant, during unpacking and outside the patient, a puncture was noticed in the paper peel back label making the product unsterile.There was no damage to the outside box and the puncture in the paper did not occur in the process of opening the device.The procedure was completed with another uphold (tm) lite with capio slim device.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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