SCALER

Additional Manufacturer Narrative

HU-FRIEDY REQUESTED ADDITIONAL INFORMATION FROM THE USER FACILITY REGARDING THE SCALER INCLUDING THE MODEL AND LOT NUMBER AND THAT THE DEVICE BE RETURNED FOR EVALUATION; HOWEVER, THE USER FACILITY DECLINED. SHOULD WE OBTAIN ADDITIONAL INFORMATION REGARDING THE SPECIFIC DEVICE SUBJECT OF THIS EVENT, A FOLLOW-UP MDR WILL BE SUBMITTED WITH THE RESULTS OF OUR INVESTIGATION.

Description of Event or Problem

THE USER FACILITY REPORTED THAT UPON OPENING THE PACKAGING OF A SCALER THE DOCTOR OBTAINED A CUT ON HIS FINGER. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.