Catalog Number BRD700SI |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
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Event Description
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It was reported that the patient had recurrent stress incontinence for several years that had re-appeared in (b)(6) 2019.The recurrent incontinence was confirmed through video urodynamic.The ajust device was inserted in the patient in 2011.The patient is awaiting further surgery to treat stress incontinence.
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Manufacturer Narrative
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The device was not returned for evaluation.A potential root cause of the reported event could be that the physician did not have proper knowledge of the patient's entire medical needs due to which cystocele repair was not performed but was needed before the device implant surgery, resulting in recurrent stress incontinence and need for additional surgery.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "anatomical distortion can result from pelvic organ prolapse.If the patient requires cystocele repair, it should be performed prior to the implantation of the sub-urethral sling.".
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Event Description
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It was reported that the patient had recurrent stress incontinence for several years that had re-appeared in may 2019.The recurrent incontinence was confirmed through video urodynamic.The ajust device was inserted in the patient in 2011.The patient is awaiting further surgery to treat stress incontinence.
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Search Alerts/Recalls
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