DEROYAL

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: (B)(4). NON-CONFORMING REPORT AND REPAIR LOG FOR THE LOT IN REFERENCE HAS BEEN CHECKED AND NO ISSUE WAS REPORTED RELATED TO PROBLEM REPORTED. (B)(4). ROOT CAUSE: THE MOST LIKELY THE INCIDENT OCCURRED DURING THE PRODUCT ASSEMBLY. A PROPER INSPECTION OF THE UNIT, PRIOR TO PACKAGING, WAS NOT PERFORMED. CORRECTIONS: NOT APPLICABLE AT MANUFACTURING FACILITY, PRODUCT WAS NOT RETURNED FOR REPLACEMENT. CORRECTIVE ACTION: INSPECTORS WITH RESPONSIBILITY OVER THE LOT NUMBER REPORTED IN THE COMPLAINT WERE IDENTIFIED. THEY WERE INFORMED ABOUT THE COMPLAINT. THEY HAVE ALSO BEEN RE-TRAINED AND INSTRUCTED TO MAKE SURE THAT A THOROUGH INSPECTION IS PERFORMED IN ALL UNITS OF A WORK ORDER IN ORDER TO AVOID ANY TYPE OF EXTERNAL MATERIAL PACKAGED WITH THE FINAL PRODUCT. THE REST OF THE INSPECTORS IN THE MANUFACTURING AREA HAVE BEEN INFORMED AND RETRAINED AS WELL. QUALITY CONTROL INSPECTORS WILL INCLUDE IN THE WEEKLY INSPECTIONS TO THE SEWING LINES, THE CHECK OF SEWING NEEDLES ARE PROPERLY STORAGE. PREVENTIVE ACTION: NOT APPLICABLE, CORRECTIVE ACTIONS HAVE BEEN TAKEN DUE THE EXISTING NONCONFORMITY FROM THE CUSTOMER NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE QUALITY ISSUE DETAILS AND THE OUTCOME DETAILS SECTION COPIED BELOW ARE RESPONSES GIVEN BY THE INITIAL REPORTER TO THE DEROYAL COMPLAINT QUESTIONNAIRE. QUALITY ISSUE DETAILS: DATE OF OCCURRENCE: (B)(6) 2016. WHEN DID QUALITY ISSUE OCCUR? BEFORE USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? HEALTH PROFESSIONAL. WAS A MEDICAL PROCEDURE INVOLVED? NO. NAME OF MEDICAL PROCEDURE: NOT APPLICABLE. DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NOT APPLICABLE. DETAILED DESCRIPTION OF QUALITY ISSUE: THIS IS A VERBAL COMPLAINT CUSTOMER SAID THAT THE WHEN THE NURSE OPENED UP THE ABDOMINAL BINDER TO PUT ON THE PATIENT THERE WAS A SEWING NEEDLE STUCK IN THE TOP PANEL WHERE THE PANELS ARE STITCHED TOGETHER. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY VISUAL INSPECTION. HOW WAS THE PRODUCT BEING USED? THERAPY. WAS IT THE INITIAL USE OF THE PRODUCT? YES. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? NO. OUTCOME DETAILS: OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: NONE. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: N/A. WAS THE INCIDENT REPORTED TO THE FDA? NO. DETAILED DESCRIPTION OF OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: N/A.