As reported, during an unknown procedure, the unopened package of a ureteral diversion stent set contained a foreign substance.The device was not used.Another device of the same type was used to complete the procedure.There were no adverse effects to the patient reported.
|
Blank fields on this form indicate the information is unknown or unavailable.G4: device is not marketed in the united states.There are similar devices marketed in the united states, for example catalog number 025807-s1.Information for 025807-s1: pma/510(k) # (g4): = k181971.H3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|