Updated: describe event or problem.Investigation summary: based on the information available, the cause that contributed to the reported urinary retention and urinary incontinence cannot be established as the product is not available for analysis.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the slings-mens instructions for use (ifu).The sling-mens ifu lists urinary incontinence and urinary retention as a potential adverse event(s) associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
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