BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KERRALITE COOL

    MDR report key: 8903800 · Received August 16, 2019

    Report

    Report Number
    3004051837-2019-00008
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 16, 2019
    Report Date
    August 5, 2019
    Manufacturer
    CRAWFORD HEALTHCARE LTD
    Product Code
    NAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE DEVICE IS UNKNOWN. UNABLE TO COMPLETE FURTHER ANALYSIS ON SPECIFIC BATCH. COMPLAINT TRENDING REVIEW IDENTIFIED NO OTHER COMPLAINTS OF THIS TYPE OCCURRING. THE CUSTOMER WAS CONTACTED FOR FURTHER INFORMATION: WHAT IS THE EXACT AETIOLOGY OF THE WOUND LOCATED ON THE PATIENTS SHIN, SIZE AND HOW LONG HAS THE WOUND BEEN PRESENT? HOW LONG HAVE YOU BEEN DRESSING THE WOUND WITH KERRALITE COOL, HOW MANY DRESSING CHANGES (IF KNOWN)? WHICH KERRALITE COOL DRESSING DID YOU USE? E.G. BORDER OR NON-BORDER & SIZE? HOW DID THE WOUND PRESENT AFTER THE REMOVAL OF KERRALITE COOL E.G. SURROUNDING SKIN / GRANULATING TISSUE / EXUDATE LEVELS/ INFECTION? HAS THE PATIENT EVER EXPERIENCED ANYTHING SIMILAR IN THE PAST? HAS THE PATIENT RECENTLY CHANGED ANY MEDICATION OR TREATMENTS? DOES THE PATIENT HAVE ANY COMORBIDITIES? CUSTOMER PROVIDED ADDITIONAL INFORMATION. PATIENT HAD LONG STANDING LEG ULCER OVER THE SHIN AREA WHICH HAD BEEN PRESENT FOR OVER 12 MONTHS. NO REAL CHANGE IN APPEARANCE. HAS HAD DIFFERENT DRESSINGS WITH NO CHANGE REALLY. HAD A TRIAL OF URGOSTART AS PATIENT HAD SEEN PRODUCT AND ASKED G P TO PRESCRIBE. PRIOR TO APPLICATION OF KERRALITE WOUND MEASURED 8.0CM L X 1.5CM W SUPERFICIAL 25% SLOUGH, 60% GRANULATION WITH 15 % EPITHELIALIZED TISSUE. KERRALITE NON BORDERED 12X8.5CM APPLIED ON (B)(6) 2019 FULL DRESSING WAS PLACED AND WAS NOT CUT TO SIZE. XUPAD WAS APPLIED TO PROTECT SHIN AREA. (HAS ALWAYS HAD THIS). URGO K TWO COMPRESSION BANDAGE SYSTEM APPLIED WHEN THE DRESSING WAS REMOVED (B)(6) 2019. DRY SKIN NOTED ON KERRALITE COOL WOUND NOT MEASURED DUE TO INCIDENT OCCURRING. SMALL AMOUNT OF CONGEALED BLOOD TO SIDE OF WOUND. THERE DID SEEM TO BE AN UNUSUAL DEEPER INDENTATION FROM THE XUPAD ON REMOVAL. A HAEMATOMA TO SKIN NOTED (NEXT TO WOUND) ON TOUCHING BLOOD SPIRTED. STOPPED WITH PRESSURE AND ALGINATE. THE TVN CAME WITH A DRESSING PRODUCT USED TO HELP STOP THE BLEEDING, BUT IT WAS ALREADY STOPPED. INADINE WAS APPLIED AS DIRECTED BY HER. PATIENT CONTACTED (B)(6) 2019 NO FURTHER BLEEDING, HAS HAD STABBING PAIN BUT HAS HAD THIS BEFORE FOR REVIEW ON (B)(6) 2019. IN ADDITION TO THE DETAILS RECEIVED ON THE WOUND IT WAS REPORTED THAT THE PATIENT HAD SEVERAL HEALTH ISSUES: HISTORY OF CKD STAGE 5; DIAPHRAGMATIC HERNIA; MILD DEPRESSION; AMBLYOPIA; TYPE 2 DIABETES; COPD; CERVICAL SPONDYLOSIS; HYPERTENSION; IHD; OBESITY; OSTEOARTHRITIS. COMPLAINT LOGS FROM 2013 TO CURRENT DATE WERE REVIEWED. NO OTHER INCIDENTS OF THIS TYPE HAVE BEEN PREVIOUSLY REPORTED WITH THE KERRALITE COOL DEVICE SINCE THE DEVICE WAS FIRST PLACED ON THE MARKET IN 2013. THE KERRALITE COOL-RISK MANAGEMENT REV 1 WAS REVIEWED AND CURRENTLY THERE IS NO RISK IDENTIFIED OF A HAEMATOMA DEVELOPING. THE PATIENT OUTCOME WAS NOT OF SERIOUS INJURY OR DEATH, MEDICAL INTERVENTION WAS APPLIED TO STOP THE BLEED FROM THE HAEMATOMA HOWEVER NO FURTHER BLEEDING WAS REPORTED FOLLOWING THIS. THERE WAS NO IDENTIFIED MALFUNCTION OF THE DEVICE AND FURTHER COMMUNICATION FROM THE CUSTOMER STATED THAT THE CUSTOMER FELT THAT THE ADVERSE EVENT WAS PROBABLY NOT THE PRODUCT AND MORE LIKELY AN APPLICATION ISSUE FOR THE PATIENT.

    Description of Event or Problem · 1

    PHONE CALL TOOK PLACE BETWEEN CUSTOMER AND TERRITORY MANAGER. INITIAL INFORMATION TAKEN FROM EMAIL COMMUNICATION. PATIENT WITH LEG ULCER HAS BEEN TREATED USING KERRALITE COOL. IT HAS BEEN REPORTED THAT UPON REMOVAL OF THE DRESSING THE LEG ULCER HAD STARTED TO BLEED. IT WAS STATED IN THE EMAIL COMMUNICATION THAT THE AMOUNT OF BLOOD PRESENTED AFTER REMOVAL OF THE DRESSING WAS OVERWHELMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697611 KERRALITE COOL KERRALITE COOL, PRODUCT CODE: NAE NAE CRAWFORD HEALTHCARE LTD CWL1005

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other