BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPRASORB X+PHMB

    MDR report key: 10219876 · Received July 1, 2020

    Report

    Report Number
    9611462-2020-00001
    Event Type
    Death
    Date Received
    July 1, 2020
    Date of Event
    February 3, 2020
    Report Date
    June 5, 2020
    Manufacturer
    LOHMANN & RAUSCHER GMBH & CO
    Product Code
    MGQ
    UDI-DI
    04021447924816
    PMA / PMN Number
    K024054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOHMANN & RAUSCHER (B)(4) AS A FOREIGN MANUFACTURER IS REPORTING AN ADVERSE EVENT AS IDENTIFIED IN (B)(6) FOR SUPRSORB X+PHMB AS THE MANUFACTURER. WHILE SUPRASORB X+PHMB WAS NEVER DISTRIBUTED WITHIN THE USA IT IS A FDA LISTED DEVICE FOR LOHMANN & RAUSCHER (B)(4); HOWEVER, A SIMILAR DEVICE WAS DISTRIBUTED AS XCELL¿ CELLULOSE WOUND DRESSING ANTIMICROBIAL, STERILE 3.5 IN. X 3.5 IN. UNDER THE LOHMAN & RAUSCHER BRAND AND WAS DISTRIBUTED WITHIN THE USA. THIS PRODUCT WAS LAST SOLD IN THE USA ON SEPTEMBER 2018, WITH THE LAST PRODUCT DISTRIBUTED SUBSEQUENTLY EXCEEDING IT'S EXPIRATION DATE. BOTH SUPRASORB X+PHMB AND XCELL ANTIMICROBIAL PRODUCTS HAVE BEEN DISCONTINUED, AND LOHMANN & RAUSCHER WILL DELIST LISTING E616736 FROM FDA DATABASE ASSOCIATED WITH PRODUCT CODE MGQ. ADDITIONALLY, LOHMANN & RAUSCHER'S US SUBSIDIARY (B)(4) (IMPORTER) WILL ALSO REMOVE LISTING, D297355, FOR XCELL AND SUPRASORB X ASSOCIATED WITH PRODUCT CODE MGQ. REFERENCE L&R USA INC.'S MDR (B)(4).

    Description of Event or Problem · 1

    THROUGH THIS COMMUNICATION, ON BEHALF OF LOHMANN & RAUSCHER WE WOULD LIKE TO INFORM YOU THAT ON (B)(6) 2020, WE RECEIVED A REPORT FROM DR. (B)(6) OF THE BURNED CHILDREN UNIT OF THE STATE CENTER FOR CRITICAL CARE IN (B)(6), INSTITUTE OF PUBLIC HEALTH OF THE STATE OF (B)(6), REFERRING TO A (B)(6)-YEAR-OLD MALE CHILD WHO WAS ADMITTED TO THE GENERAL HOSPITAL OF (B)(6) DUE TO A BURN WITH HOT WATER SUFFERED ON (B)(6) ON THE GENITAL AREA AND THE LOWER EXTREMITIES (APPROX. 21% OF THE BODY AREA) AND WHO WAS LATER TRANSFERRED TO THE BURNED CHILDREN UNIT OF THE STATE CENTER FOR CRITICAL CARE OF (B)(6), INSTITUTE OF PUBLIC HEALTH OF THE STATE OF (B)(6) ON (B)(6). AFTER THE 3RD SURGICAL DEBRIDEMENT THE CHILD WAS TREATED WITH 5 PIECES OF OUR SUPRASORB X+PHMB WOUND DRESSING (14X20CM, REF 20542, LOT 1913311905) FOR 4-5 DAYS WITHOUT ANY CHANGE DRESSING (FIXED AS SECONDARY DRESSING WITH AN UNELASTIC BANDAGE. ACCORDING TO THE MEDICAL REPORT AND THE COFEBRIS REPORT SENT BY DR. (B)(6) TO US THE FIRST SYMPTOMS WERE PRESENTED BY THE PATIENT IN THE FIRST 24 H UP TO SEVERE LIVER FAILURE AND ACUTE KIDNEY FAILURE AND LATER DIED ON (B)(6). THE PATIENT WAS CO-TREATED WITH DIFFERENT MEDICATIONS SUCH AS PARACETAMOL, DEXMEDETOMIDINE, DIPHENHYDRAMINE, LORATADINE, CEPHALOTIN, AMIKACIN, DIPHENHYDRAMINE, ALBENDAZOLE, AMONG OTHERS, AND ADDITIONALLY DURING TREATMENT, THE SUPRASORB X + PHMB WOUND DRESSING WAS USED. LOHMANN & RAUSCHER IS CURRENTLY CONDUCTING AN EVALUATION OF THIS CASE IN ORDER TO DETERMINE THE CAUSAL RELATIONSHIP (IF THERE IS ANY CORRELATION BETWEEN THE EVENT PRESENTED AND THE USE OF THE SUPRASORB X + PHMB WOUND DRESSING). ONCE THE EVALUATION HAS BEEN COMPLETED, WE WILL SUBMIT A NEW NOTIFICATION TO YOU WITH THE RESULTS.

    Additional Manufacturer Narrative · 2

    LOHMANN & RAUSCHER (B)(4) AS A FOREIGN MANUFACTURER IS REPORTING AN ADVERSE EVENT AS IDENTIFIED IN (B)(6) FOR SUPRSORB X+PHMB AS THE MANUFACTURER. WHILE SUPRASORB X+PHMB WAS NEVER DISTRIBUTED WITHIN THE USA A SIMILAR DEVICE WAS DISTRIBUTED AS XCELL¿ CELLULOSE WOUND DRESSING ANTIMICROBIAL, STERILE 3.5 IN. X 3.5 IN. UNDER THE LOHMAN & RAUSCHER BRAND AND DISTRIBUTED WITHIN THE USA BY L&R USA INC.. THIS PRODUCT WAS LAST SOLD IN THE USA ON (B)(6) 2018, WITH THE LAST PRODUCT DISTRIBUTED SUBSEQUENTLY EXCEEDING IT'S EXPIRATION DATE. XCELL PRODUCTS HAVE BEEN DISCONTINUED, AND LOHMANN & RAUSCHER WILL DELIST LISTING (B)(4) FROM FDA DATABASE ASSOCIATED WITH PRODUCT CODE MGQ. ADDITIONALLY, LOHMANN & RAUSCHER'S US SUBSIDIARY (B)(4) (IMPORTER) WILL ALSO REMOVE LISTING, (B)(4), FOR XCELL ASSOCIATED WITH PRODUCT CODE MGQ. REFERENCE L&R USA (B)(4) MDR (B)(4). FOLLOW UP REPORT WITH INFORMATION BASED UPON FDA REQUEST, AI LETTER (B)(4). LOHMANN & RAUSCHER (B)(4) FORMAL RESPONSE TO REQUESTED INFORMATION CAN BE FOUND IN ATTACHMENT 5. THIS RESPONSE INCLUDES REFERENCES TO (B)(4), WHICH IS THE REPORTING FACILITY'S EVENT HISTORY ANALYSIS SUMMARY AS (B)(4).

    Description of Event or Problem · 2

    THROUGH THIS COMMUNICATION, ON BEHALF OF LOHMANN & RAUSCHER WE WOULD LIKE TO INFORM YOU THAT ON THE (B)(6) 2020, WE RECEIVED A REPORT FROM DR. (B)(6) OF THE BURNED (B)(6) UNIT OF THE STATE CENTER FOR CRITICAL CARE IN (B)(6), INSTITUTE OF PUBLIC HEALTH OF THE STATE OF (B)(6), REFERRING TO A (B)(6)-YEAR-OLD MALE CHILD WHO WAS ADMITTED TO THE GENERAL HOSPITAL OF (B)(6) DUE TO A BURN WITH HOT WATER SUFFERED ON (B)(6) ON THE GENITAL AREA AND THE LOWER EXTREMITIES (APPROX. 21% OF THE BODY AREA) AND WHO WAS LATER TRANSFERRED TO THE BURNED (B)(6) UNIT OF THE STATE CENTER FOR CRITICAL CARE OF (B)(6), INSTITUTE OF PUBLIC HEALTH OF THE STATE OF (B)(6) ON (B)(6). AFTER THE 3RD SURGICAL DEBRIDEMENT THE CHILD WAS TREATED WITH 5 PIECES OF OUR SUPRASORB X+PHMB WOUND DRESSING (14X20CM, REF 20542, LOT 1913311905, DESCRIPTION) FOR 4-5 DAYS WITHOUT ANY CHANGE DRESSING (FIXED AS SECONDARY DRESSING WITH AN UNELASTIC BANDAGE. ACCORDING TO THE MEDICAL REPORT AND THE COFEBRIS REPORT SENT BY DR. (B)(6) TO US THE FIRST SYMPTOMS WERE PRESENTED BY THE PATIENT IN THE FIRST 24 HR UP TO SEVERE LIVER FAILURE AND ACUTE KIDNEY FAILURE AND LATER DIED ON (B)(6). THE PATIENT WAS CO-TREATED WITH DIFFERENT MEDICATIONS SUCH AS PARACETAMOL, DEXMEDETOMIDINE, DIPHENHYDRAMINE, LORATADINE, CEPHALOTIN, AMIKACIN, DIPHENHYDRAMINE, ALBENDAZOLE, AMONG OTHERS, AND ADDITIONALLY DURING TREATMENT, THE SUPRASORB X + PHMB WOUND DRESSING WAS USED. FOR MORE DETAILS PLEASE REFER TO THE DOCUMENT ATTACHED WHICH CORRESPONDS TO THE CLINICAL HISTORY OF THE PATIENT RECEIVED BY DR. (B)(6) (RECEIVED (B)(6) 2020) AS WELL AS THE REPORT MADE BY DR. (B)(6) TO COFEPRIS (RECEIVED (B)(6) 2020). LOHMANN & RAUSCHER IS CURRENTLY CONDUCTING AN EVALUATION OF THIS CASE IN ORDER TO DETERMINE THE CAUSAL RELATIONSHIP (IF THERE IS ANY CORRELATION BETWEEN THE EVENT PRESENTED AND THE USE OF THE SUPRASORB X + PHMB WOUND DRESSING). ONCE THE EVALUATION HAS BEEN COMPLETED, WE WILL SUBMIT A NEW NOTIFICATION TO YOU WITH THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684110 SUPRASORB X+PHMB ANTIMICROBIAL WOUND DRESSING MGQ LOHMANN & RAUSCHER GMBH & CO 14X20CM 1913311905 04021447924816

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death| D
    2 5 YR Death