It was reported that the ear ulcer syringe "appears to be much thicker and it's difficult to compress." to date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A sample was provided for evaluation and investigation identified the reported problem/issue to not be a product defect as the sample met specifications.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
|