BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL

    MDR report key: 6354170 · Received February 23, 2017

    Report

    Report Number
    3006851902-2017-00005
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    January 26, 2017
    Report Date
    January 26, 2017
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    ITW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CALL REPORTED SKIN BREAK DOWN. THERE WERE NO OTHER DETAILS PROVIDED. NO SAMPLE WAS RETURNED. SALES REPRESENTATIVE HAS ATTEMPTED TO OBTAIN MORE DETAILS FROM CUSTOMER AND HAS NOT BEEN SUCCESSFUL. WITHOUT ANY FURTHER INFORMATION, THE INVESTIGATION TEAM IS UNABLE TO DETERMINE ROOT CAUSE. THIS IS ONE OF THREE COMPLAINTS THAT CAME IN AT THE SAME TIME FOR THE SAME LINE OF PRODUCT FROM THE SAME USER FACILITY. COMPLAINT HISTORY BETWEEN 01-01-2012 TO 12-30-2016 WAS REVIEWED. THERE ARE NO OTHER SKIN BREAKDOWN COMPLAINTS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CALL REPORTED SKIN BREAK DOWN. THERE WERE NO OTHER DETAILS PROVIDED. NO SAMPLE WAS RETURNED. SALES REPRESENTATIVE HAS ATTEMPED TO OBTAIN MORE DETAILS FROM CUSTOMER AND HAS NOT BEEN SUCCESSFUL. WITHOUT ANY FURTHER INFORMATION, THE INVESTIGATION TEAM IS UNABLE TO DETERMINE ROOT CAUSE. THIS IS ONE OF THREE COMPLAINTS THAT CAME IN AT THE SAME TIME FOR THE SAME LINE OF PRODUCT FROM THE SAME USER FACILITY. COMPLAINT HISTORY BETWEEN 01-01-2012 TO 12-30-2016 WAS REVIEWED. THERE ARE NO OTHER SKIN BREAKDOWN COMPLAINTS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    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: SKIN BREAK DOWN WITH BOOT- HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY ACTUAL USE. HOW WAS THE PRODUCT BEING USED? FOR POSITIONING / PRESSURE REDUCTION. 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: OTHER. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: SKIN BREAKDOWN. WAS THE INCIDENT REPORTED TO THE FDA? NO.

    Description of Event or Problem · 1

    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; DETAILED DESCRIPTION OF QUALITY ISSUE: SKIN BREAK DOWN WITH BOOT; HOW WAS THE QUALITY ISSUE WAS IDENTIFIED: BY ACTUAL USE; HOW WAS THE PRODUCT BEING USED: FOR POSITIONING / PRESSURE REDUCTION; 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: OTHER; PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE; KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: SKIN BREAKDOWN; WAS THE INCIDENT REPORTED TO THE FDA: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134986 DEROYAL ANKLE CONTRACTURE BOOT ITW DEROYAL INDUSTRIES, INC. 4302B

    Patients

    Seq Age Sex Outcome Treatment
    1