BOSTON SCIENTIFIC - MARLBOROUGH OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068504000 |
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 03/20/2015 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that an obtryx curved single system device was opened for use in a transobturator taping procedure performed on (b)(6) 2015.According to the complainant, when they opened the sling from the outer box, the front plastic part of the inner pouch was punctured with a pin-sized hole.The procedure was completed with another obtryx curved single system device.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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Manufacturer Narrative
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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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Search Alerts/Recalls
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