BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068504000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/02/2008 |
Event Type
Injury
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Manufacturer Narrative
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Other: health (b)(6) incident report reference no.(b)(4).The device was implanted and is not expected to 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 obtryx system - curved device had been implanted in the patient for eleven years.Due to the mesh implant, the patient experienced difficulty walking, sitting, standing and spent her days lying down due to pain.The patient's physical and mental energy were also affected severely because of umbilical hernia due to intestine remained bloated and so on.
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Search Alerts/Recalls
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