Product complaint # (b)(4).Additional information was requested, and the following was obtained via phone: contacted patient through phone number provided on event description.Stitches were removed on her physicians office.No additional intervention was required.No infection was present.As mentioned in event description, patient is asking for guidelines for use of the suture used in her procedure and is concerned about having the same reaction with the product in the future.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Events reported via: 2210968-2021-04783 and 2210968-2021-04784.
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It was reported that a patient underwent a breast augmentation procedure on an unknown date and suture was used.Post-operatively, the patient stated that the suture left ropelike incision marks, suture did not dissolve and started to work its way through the skin right away.Patient stated that she waited a little while thinking it was the steri-strips.Patient was told ten days after surgery that her stitches were out, and the rest would dissolve.Patient was unhappy with the surgery and did not go back to the surgeon.When they started working their way through the skin, she went to a surgeon she¿s seen from a previous surgery.This surgeon removed 23 stitches that had worked their way through enough to be removed.Patient returned to the original surgeon four and a half months post op to complain and have additional stitches removed which surgeon stated she would have to come back because they were only partially way through.Patient stated that her areola is now misshapen and hard.Patient asking for guidelines for use of the suture used in her procedure.Reported.Additional information was requested.
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