A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.Since the band was disposed of at the hospital, no physical, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.The difficulty with the nile band is consistent with improper technique.Tightening a set screw on a band and repositioning can cause stress risers in the band.While the implant was not returned, a general review of the manufacturing and inspection records revealed no additional information.Hospital disposed of device.
|