BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 3761035 · Received April 15, 2014

    Report

    Report Number
    1000317571-2014-00016
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    February 18, 2014
    Report Date
    March 21, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    NAE
    PMA / PMN Number
    K973806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY; HOWEVER, REPORT STATES THE COMPLAINT IS NOT RELATED TO THE DRESSING USE, BUT REALLOCATION OF POSTOPERATIVE HEALINGS AT THE SAME INSTITUTION WHERE HE WAS OPERATED. CASE WAS EVALUATED BY QUALITY ON (B)(6) 2014 BASED ON THE REVIEW OF THE BATCH RECORD FOR DUE DILIGENCE. RESULTS SHOW THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. IN ADDITION, THE COMPLAINT LETTER STATES THAT THE COMPLAINT IS NOT REGARDING THE DRESSING BUT THE REALLOCATION OF HEALINGS AT THE INSTITUTION. NO FURTHER ACTION REQUIRED AS PER CONVATEC GOVERNING COMPLAINT AND HANDLING PROCEDURE. REPORTED TO THE FDA ON (B)(4) 2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO IT'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    DAUGHTER OF PATIENT REPORTED THAT PATIENT WAS BEING TREATED WITH HEALING FOR MULTIPLE WOUNDS ON BOTH LEGS WITH ORAL ANTIBIOTICS AND VARIOUS DRESSINGS, WHICH BECAME INFECTED AND HE WAS TAKEN TO EMERGENCY WHERE HE WAS HOSPITALIZED FROM (B)(6) 2014 RESULTING IN AMPUTATION FROM HIS LEFT LEG (UNKNOWN LEVEL). SUMMARY OF PATIENT CARE AS FOLLOWS: THE PATIENT ADMISSION TO THE HOSPITAL FOR CURES ON (B)(6) 2014, RELATED TO THREE TRAUMATIC LOWER LIMB INJURIES. PATIENT ENTERED TO THE APPOINTMENT ON CRUTCHES. THE WOUND ASSESSMENT AT ADMISSION THREE LESIONS WERE FOUND: INJURY TO THE MIDDLE THIRD OF LOWER LEFT MEMBER 8X8.5CM WITH 100% DRY NECROTIC TISSUE, PERILESIONAL SKIN WITH REDNESS, HEAT, SWELLING, PAIN (SIGNS OF INFECTION); INJURY TO THE MIDDLE THIRD RIGHT LOWER FRONTAL MEMBER 1X1CM WITH 100% DRY NECROTIC TISSUE AND ADHERED; WOUNDED IN RIGHT KNEE 1X1CM ON RIGHT KNEE WITH 100% NECROTIC TISSUE, PERILESIONAL HEALTHY SKIN. TREATMENT WAS INITIATED WITH DUODERM GEL TO PROMOTE DEBRIDEMENT OF NECROTIC TISSUE, AGUACEL AG FOR HANDLING OF LOCAL BACTERIA LOAD, AND DUODERM CGF DRESSING TO ADD MOISTURE TO THE WOUND. HEALINGS WERE SCHEDULED EVERY FIVE DAYS. PATIENT AND FAMILY WERE EDUCATED IN DRESSINGS' TECHNOLOGY BEHAVIOR, ESPECIALLY THE EFFECT OF DEBRIDEMENT CAUSING AN INCREASE IN THE SIZE OF THE WOUNDS. INDICATIONS WERE GIVEN FOR WARNING SIGNS. DURING HEALING MADE BETWEEN (B)(6) 2014, IT WAS OBSERVED THAT NECROTIC TISSUE STILL PERSISTS AS EVIDENCED BY WETTER AND ENLARGED WOUNDS (DEBRIDEMENT EFFECT, EQUAL MANAGEMENT WAS CONTINUED AND HAVING PRESENT THAT THE PATIENT HAD SIGNIFICANTLY INCREASED IN PAIN, EDEMA). FLUSHING IT AND WAS TOLD TO CONSULT HIS DOCTOR. ON (B)(6) 2014, PATIENT WAS ASSISTED TO THE APPOINTMENT DUE TO DIFFICULTIES WALKING, EDEMA GRADE II, AND TWO INJURED MORE APPEARANCE AND REMARKABLE ENLARGEMENT OF EXISTING WOUNDS: WOUND NO. 1: MIDDLE THIRD LOWER LEFT MEMBER 14X13CM WITH 100% WET NECROTIC TISSUE, SLOUGH EDGES, WITH SIGNS OF INFECTION; WOUND NO. 2: INJURY ON FRONTAL MIDDLE THIRD LOWER RIGHT MEMBER 18X7CM WITH 30% WET AND 70% NECROTIC TISSUE GRANULATION, HEAVY EXUDATE, WITH SIGNS OF INFECTION; WOUND NO. 3: INJURY 1X1CM RIGHT KNEE WITH 100% FIBRIN TISSUE. MACERATED EDGES NEW LESIONS; WOUND NO. 4: INJURY ON FRONTAL THIRD PROXIMAL LEFT LOWER, MEMBER 8X5C BOTTOM WITH BLEEDING, HIGHLY EXUDATIVE; WOUND NO. 5: INJURY SUPRAMALLEOLAR EXTERNAL REGION OF LEFT LOWER LIMB WITH GRANULAR BACKGROUND 6X4CM. MANAGEMENT CONTINUES WITH AGUACEL AG, DUODERM GEL AND DUODERM CGF. PATIENT AND FAMILY (SON) WAS INFORMED ON THE IMPORTANCE OF BEING EVALUATED BY AN INTERNISTS DUE TO DETERIORATION OF GENERAL CONDITION, AND THE WOUND IS VERY STRONG WHICH REQUIRES ANCILLARY DIAGNOSTIC TESTS. FAMILY REPORTED THAT PATIENT ALREADY HAD A SCHEDULED APPOINTMENT WITH DOCTOR FOR EVALUATION. ON (B)(6) 2014, PATIENT ENTERS TO HEALING PROCESS ON WHEELCHAIR, IN POOR GENERAL CONDITION, PALE POLIPNEA. FAMILY REPORTED THAT PATIENT HAS NOT BEEN EATING WELL (DIABETIC). RIGHT FRONTAL WOUND OF LOWER LIMB, IN ADDITION TO WHAT WAS DESCRIBED IN THE PREVIOUS HEALING PRESENTED WITH ISCHEMIC EDGES, SURROUNDING WITH SLOUGH SKIN, EDEMA GRADE III, WEAK PULSES WITHOUT CAPILLARY REFILL. WOUND ON THE THIRD DISTAL OUTER SIDE OF THE LEG: 8X7CM 100% WET NECROTIC TISSUE, ISCHEMIC EDGES SURROUNDING SKIN MACERATED, INCREASED SERIOUS EXUDATES, EDEMA GRADE IV DECREASED POPLITEAL PULSE, NO PALPABLE PEDAL AND TIBIAL, WITHOUT CAPILLARY REFILL, COLD EXTREMITY. DUE TO THE MARKED DETERIORATION, AND PATIENT NOT YET BEEN EVALUATED BY THE PHYSICIAN, WOUND HEALING WAS DONE. FAMILY WAS INFORMED THAT HE BE TAKEN TO EMERGENCY ASSESSMENT BY HIS EPS. IN CONCLUSION, IT IS REPORTED THAT WHEN IT WAS IDENTIFIED THAT THE PATIENT DID NOT IMPROVE AND HAD NOT BEEN REVIEWED BY A PHYSICIAN (AS RECOMMENDED), THS NURSE WHO REFERRED HIM TO THE EMERGENCY SERVICE, IN ADDITION TO HIS UNDERLYING PREEXISTING MEDICAL CONDITION, MAY HAVE PUT HIM AT GREATER RISK OF COMPLICATION. TREATMENT WAS PERFORMED TO THE PATIENT AIMED AT ENHANCING AUTOLYTIC DEBRIDEMENT OF ALL NECROTIC LESIONS BEING THE PREDOMINANT TISSUE IN ALL WOUNDS AND AQUACEL AG TO DECREASE LOCAL BACTERIAL LOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229429 MOISTURE RETENTIVE DUODERM CGF DRESSING HYDROGEL WOUND AND BURN DRESSING, 79 NAE NAE CONVATEC LIMITED 187987 3H02261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention