BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SORBACT ABSORPTION DRESSING

    MDR report key: 9396625 · Received December 2, 2019

    Report

    Report Number
    8043991-2019-00003
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    September 25, 2019
    Report Date
    January 16, 2020
    Manufacturer
    ABIGO MEDICAL AB
    Product Code
    FRO
    PMA / PMN Number
    K063059
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE BATCH NUMBER WAS NOT PROVIDED, BATCH RECORDS COULD NOT BE REVIEWED, BUT THERE IS NOTHING IN THE PROVIDED INFORMATION INDICATING THAT THE DEVICE HAS BEEN DEFECTIVE. ACCORDING TO THE PROVIDED INFORMATION, THE DEVICE WAS USED FOR MANAGEMENT OF FUNGAL INFECTION OF SUBMAMMARY FOLDS, WHICH IS OUTSIDE THE INTENDED USE. SORBACT ABSORPTION DRESSING IS INTENDED FOR USE IN MANAGEMENT OF CLEAN, CONTAMINATED, COLONIZED OR INFECTED WOUNDS WITH MODERATE TO HIGH EXUDATE LEVELS, SUCH AS SURGICAL WOUNDS, TRAUMATIC WOUNDS, PRESSURE ULCERS, DIABETIC ULCERS AND FOOT AND LEG ULCERS. HOWEVER, THE USE OUTSIDE INTENDED USE IS NOT DEEMED TO HAVE ANY CONNECTION WITH THE INCIDENT PER SE. AS STATED IN THE INSTRUCTIONS FOR USE, THE DRESSING IS A FUNGI BINDING WOUND DRESSING AND IT CAN BE APPLIED TO INTACT SKIN AS IT SHALL BE APPLIED OVERLAPPING TO THE WOUND. THE SEVERITY OF THE REACTION WAS INITIALLY ASSESSED AS SERIOUS BASED ON SUSPICION ON A POTENTIAL SYSTEMIC ALLERGIC REACTION AS A REACTION WAS NOTED NOT ONLY AT THE SITE OF APPLICATION BUT ALSO AT THE THIGHS. HOWEVER, DURING THE INVESTIGATION OF THE INCIDENT, CLINICAL EXPERTISE HAS MADE A DETAILED ANALYSIS OF ALL AVAILABLE INFORMATION AND CONCLUDED THAT THE REACTION REPORTED IS A LOCAL NON-SERIOUS HYPERSENSITIVITY REACTION (CONTACT DERMATITIS) UNDER THE DRESSING. THERE WAS NO GENERAL ALLERGIC REACTION AND AS THE REACTION DISAPPEARED SPONTANEOUSLY WITHOUT TREATMENT WITH CORTICOSTEROIDS (ONLY SYMPTOMATIC TREATMENT WITH ANTIHISTAMINE), THE REACTION AT THE THIGHS IS NOT DEEMED TO HAVE BEEN CAUSED BY SORBACT ABSORPTION DRESSING AND THERE IS NO LONGER ANY SUSPICION OF A SYSTEMIC ALLERGIC REACTION. THE FACT THAT TWO VERY SIMILAR INCIDENTS (ABIGO REFERENCE NUMBERS (B)(4)) WERE REPORTED TO HAVE OCCURRED THE SAME DAY IN THE SAME HOSPITAL INDICATES THAT THE REACTION ON THE THIGHS RATHER HAS A COMMON EXTERNAL CAUSE. TAKEN TOGETHER, THE SEVERITY OF THE REPORTED REACTION IS NOW ASSESSED AS NON-SERIOUS AND THE INCIDENT CONSIDERED NONREPORTABLE.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED 2019-12-17: NO TREATMENT BY ECONAZOLE HAD BEEN IMPLEMENTED FOR THIS PATIENT BEFORE SORBACT. IT IS IN CONTRADICTION WITH HER FIRST NOTIFICATION. AS THE FIRST NOTIFICATION WAS DEALING WITH 2 PATIENTS IT MIGHT HAVE BEEN A MISUNDERSTANDING. HER ANSWER IS CLEAR, THIS PATIENT HAD NOT BEEN TREATED BY ECONAZOLE BEFORE SORBACT.

    Description of Event or Problem · 1

    NARRATIVE FROM CUSTOMER: (B)(6) FEMALE PATIENT (BIRTH DATE (B)(6) 1927) WITH FUNGAL INFECTION OF THE FOLDS (SUBMAMMARY). TREATED WITH SORBACT ABSORPTION DRESSING. 2 DAYS AFTER THE BEGINNING OF THE TREATMENT ( (B)(6) 2019), APPEARANCE OF A CUTANEOUS REACTION: ERYTHEMA, HEAT AND EDEMA, UNDER THE DRESSING BUT ALSO AT THE LEVEL OF THE THIGHS. REMOVAL OF THE DRESSING AND MANAGEMENT OF THE REACTION BY DESLORATADINE (AERIUS). DISAPPEARANCE OF THE REACTION IN A FEW DAYS. WE DO NOT HAVE MORE DATA REGARDING THE BATCH NUMBER NOR THE REFERENCE (PHARMACIST TOLD ME THAT AS SHE HAS MORE 10X10 IN STOCK THAN 10X20, THE USED DRESSING WAS PROBABLY 10X10CM). ANSWERS TO QUESTIONS: IS IT POSSIBLE TO GET PICTURE OF THE REACTION UNDER THE DRESSING (MAMMARY FOLDS)? NO PICTURE AVAILABLE. FOR HOW LONG WAS THE PRODUCT USED BEFORE THE REACTION OCCURRED? 2 DAYS. HAS THE PATIENT USED SORBACT ABSORPTION DRESSING PREVIOUSLY OR WAS THIS THE FIRST TIME? IF USED BEFORE, WERE THERE ANY PROBLEMS WITH THE PRODUCT AT THAT TIME? PLEASE DESCRIBE. IT WAS THE FIRST USE OF THE PRODUCT. WERE ANY OTHER PRODUCTS USED LOCALLY WITH SORBACT ABSORPTION DRESSING? (E.G. SECONDARY DRESSINGS, CLEANSING AGENTS, ANTISEPTICS, CREAMS, GELS, OR OTHER PRODUCTS)? IF YES, PLEASE NAME. WATER + SOAP + DRYING. PREVIOUS TREATMENT BY ECONAZOLE HAD BEEN DISCONTINUED DURING SORBACT TREATMENT. WERE ANY PHARMACEUTICALS USED SIMULTANEOUSLY? IF SO, WHICH ONES? LAXATIVE (TRANSIPEG) EVERY 2 DAYS AND PARACETAMOL IF NEEDED. DOES THE PATIENT HAVE A MEDICAL HISTORY THAT CAN BE RELATED TO THIS EVENT? NO. DOES THE PATIENT HAVE ANY ALLERGIES? NO. ACCORDING TO PROVIDED INFORMATION SORBACT ABSORPTION DRESSING WAS USED TO MANAGE FUNGAL INFECTION OF SUBMAMMARY FOLDS. SORBACT ABSORPTION DRESSING IS INTENDED FOR USE IN MANAGEMENT OF CLEAN, CONTAMINATED, COLONIZED OR INFECTED WOUNDS WITH MODERATE TO HIGH EXUDATE LEVELS, SUCH AS SURGICAL WOUNDS, TRAUMATIC WOUNDS, PRESSURE ULCERS, DIABETIC ULCERS AND FOOT AND LEG ULCERS. COULD YOU PLEASE CONFIRM IF THE SUBMAMMARY FOLDS HAD WOUNDS WITH MODERATE TO HIGH EXUDATE LEVELS, OR IF THE PRODUCT WAS USED OUTSIDE ITS INTENDED USE? IF THE LATTER, WHY WAS SORBACT ABSORPTION DRESSING SELECTED FOR THIS INDICATION? -THERE WERE NO WOUNDS BUT IMPORTANT PERSPIRATION UNDER THE CHEST WAS PRESENT. RIBBON GAUZE ARE NOT USED IN THIS HOSPITAL. WHERE IS THE ASSOCIATED DEVICE NOW? HAS IT BEEN DISCARDED? YES IT HAS BEEN DISCARDED COULD YOU PLEASE EXPLAIN WHO WAS THE OPERATOR OF THE DEVICE; HEALTHCARE PROFESSIONAL? PATIENT/LAY USER? OTHER? -THE OPERATOR WAS A NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190986 SORBACT ABSORPTION DRESSING DRESSING, WOUND, DRUG FRO ABIGO MEDICAL AB

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention LAXATIVE (TRANSIPEG) EVERY 2 DAYS| PARACETAMOL IF NEEDED| LAXATIVE (TRANSIPEG) EVERY 2 DAYS| PARACETAMOL IF NEEDED