BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068505110 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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 ii system - halo was opened and intended to be used in a mid-urethral sling procedure performed on (b)(6) 2022.Prior the procedure, it was observed that the packaging was damaged upon opening and the device looked contaminated.The procedure was completed with another obtryx ii system - halo device.The device was not used and there were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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