DEROYAL

Additional Manufacturer Narrative

A CALL/COMPLAINT WAS RECEIVED INDICATING THAT THE "ABDOMINAL BINDER WAS APPLIED POST OP DIRECTLY NEXT TO SKIN, PATIENT BROKE OUT IN RASH". IT WAS REPORTED THAT THE SAMPLE WAS NOT AVAILABLE FOR RETURN. THE PROCESS RECORDS HAVE BEEN CHECKED AND NO ISSUES WERE FOUND RELATED TO THE PROBLEM REPORTED. (B)(4) EACH ABDOMINAL BINDERS WERE INSPECTED FROM WORK IN PROCESS AND NO ISSUES WERE FOUND DURING THE INSPECTION. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED, POSSIBLE PATIENT SENSITIVITY. THE ABDOMINAL BINDER IS MADE OF POLYESTER, NYLON AND LYCRA SPANDEX AND IS NOT MADE WITH NATURAL RUBBER LATEX. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR THIS FINISHED GOOD PRODUCT NUMBER. BETWEEN, NOVEMBER 12, 2015 - DECEMBER 20, 2017, THERE HAS BEEN ONE REPORT OF THIS MALFUNCTION FOR A PERCENTAGE OF (B)(4) UNITS SOLD, OF THIS PRODUCT FINISHED GOOD NUMBER 1140PP ABDOMINAL BINDER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE A FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

QUALITY ISSUE DETAILS: DATE OF OCCURRENCE: (B)(6) 2017. WHEN DID QUALITY ISSUE OCCUR? DURING USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? PATIENT/END CONSUMER. 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: ABDOMINAL BINDER WAS APPLIED POST OP DIRECTLY NEXT TO SKIN, PATIENT BROKE OUT IN RASH. CUSTOMER WANTS TO KNOW IF THERE ARE SPECIFICATIONS OR DIRECTIVES TO USE BINDER NEXT TO SKIN OR USE BANDAGES OR CLOTH BETWEEN BINDER AND SKIN. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY ACTUAL USE. HOW WAS THE PRODUCT BEING USED? POST OP C-SECTION. 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: IRRITATION, REACTION, RASH. DETAILS OF IRRITATION, REACTION, RASH (SEVERITY, MEDICAL TREATMENT, ETC.): NO INFO PROVIDED. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: PATIENT. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE SPECIFIED. WAS THE INCIDENT REPORTED TO THE FDA? NO. DETAILED DESCRIPTION OF OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: END USER REPORTED TO S2S.