BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICOAT FLEX3 10X10CM CTN OF 12

    MDR report key: 17690733 · Received September 6, 2023

    Report

    Report Number
    8043484-2023-00058
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    August 28, 2023
    Report Date
    August 8, 2024
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FRO
    UDI-DI
    00040565124810
    PMA / PMN Number
    K992221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: IT WAS REPORTED THAT, DURING TREATMENT OF A BREAST CANCER PATIENT, ONE (1) ACTICOAT 10X10CM CTN 12 AND VAC THERAPY WERE APPLIED ON (B)(6) 2023. THE ACTICOAT 10X10CM CTN 12 GOT STUCK IN THE WOUND AND IT WAS ABSORBED. THEY TRIED TO REMOVED THE PRODUCT ON (B)(6) 2023 BUT THE PROBLEM WAS NOT SOLVED. THE ITEM IS STILL STUCK ON THE BED AND WILL BE REMOVED SURGICALLY BY THE DOCTOR. NO OTHER COMPLICATION REPORTED. THE ORIGINAL SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION - HOWEVER THE ORIGINAL SAMPLE USED ON THE PATIENT WAS ACTICOAT FLEX3 10X10CM - LOT NUMBER IS REPORTED, THE SAMPLE RETURNED BY THE USER IS, ACTICOAT 10X10CM, LOT NUMBER REPORTED IS THE SAME AS THE REPORTED, NO VISUAL MATERIAL DEFECTS WERE FOUND ON THE RETURNED SAMPLE, THE PROBABLE CAUSE OF THE REPORTED EVENT HAS BEEN ESTABLISHED AS, INCORRECT PREPARATION AND APPLICATION ISSUES, AS STATED IN THE INSTRUCTION FOR USE FOR THE ACTICOAT FLEX 3, ¿WHEN IN USE WITH NPWT, THE WOUND FILLER MATERIAL SHOULD BE MOISTENED AND CHANGED ACCORDING TO MANUFACTURER'S INSTRUCTIONS. ACTICOAT FLEX 3 TO BE COMPATIBLE WITH NEGATIVE PRESSURE WOUND THERAPY (NPWT) FOR A PERIOD OF UP TO 3 DAYS. SHOULD THE DRESSING DRY OR ADHERE TO THE WOUND, MOISTEN, OR SOAK THE DRESSING TO ASSIST REMOVAL AND AVOID DISRUPTION OF THE HEALING WOUND, COMPLAINT HISTORY REVIEW: A REVIEW REVEALED SIMILAR INSTANCES TO THE REPORTED EVENT IN THE LAST 12 MONTHS THERE IS NOTHING TO SUGGEST THAT THIS IS OUTSIDE OF ACCEPTABLE RATES OF OCCURRENCE. THE MANUFACTURING RECORDS SHOW NO CONTRIBUTORY FACTORS RELATING TO THE REPORTED EVENT, CONFIRMING THAT THE DEVICE WAS RELEASED ACCORDING TO THE FINAL PRODUCT SPECIFICATION, WITH NO NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THIS LOT. NO FURTHER ACTIONS BY SMITH & NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. HOWEVER, WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. SMITH & NEPHEW ACKNOWLEDGE CUSTOMER CONCERN AND ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS.

    Additional Manufacturer Narrative · 0

    GIVEN THE NATURE OF THE ALLEGED INCIDENT, THE PRODUCT, COULD NOT BE RETURNED FOR EVALUATION. HOWEVER, A SAMPLE WAS RETURNED FOR EVALUATION AND NO VISUAL MATERIAL DEFECTS WERE FOUND ON THE RETURNED SAMPLE. ALSO, VIDEO WAS PROVIDED BY THE CLIENT AND CONFIRMS THE REPORTED EVENT. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, BASED ON THE INFORMATION PROVIDED BY THE WOUND CARE NURSE, THE ACTICOAT WITH VAC THERAPY DRESSINGS WERE CHANGED EVERY 4 DAYS. HOWEVER, PER THE IFU FOR THE ACTICOAT FLEX 3, ¿WHEN IN USE WITH NPWT, THE WOUND FILLER MATERIAL SHOULD BE MOISTENED AND CHANGED ACCORDING TO MANUFACTURERS¿ INSTRUCTIONS. ACTICOAT FLEX 3 TO BE COMPATIBLE WITH NEGATIVE PRESSURE WOUND THERAPY (NPWT) FOR A PERIOD OF UP TO 3 DAYS. SHOULD THE DRESSING DRY OR ADHERE TO THE WOUND, MOISTEN, OR SOAK THE DRESSING TO ASSIST REMOVAL AND AVOID DISRUPTION OF THE HEALING WOUND.¿ THEREFORE, A PROCEDURAL VARIANCE VS USER ERROR CANNOT BE RULED AS THE LIKELY CAUSE OF THE REPORTED ADVERSE EVENT. ACCORDING TO THE REPORT, THE ITEM IS STILL STUCK ON THE PATIENT¿S RIGHT BREAST WOUND BED AND WILL BE SURGICALLY REMOVED BY THE SURGEON, HOWEVER, IT IS UNKNOWN IF THE SURGERY HAS BEEN PERFORMED. THEREFORE, THE IMPACT TO THE PATIENT BEYOND THAT WHICH HAS ALREADY BEEN REPORTED CANNOT BE CONCLUDED NOR COULD THE CAUSAL RELATIONSHIP BETWEEN THE S&N DEVICE AND THE REPORTED ISSUE CANNOT BE CONFIRMED. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME BASED ON INFORMATION PROVIDED. SHOULD ANY ADDITIONAL RELEVANT MEDICAL INFORMATION BE PROVIDED, THIS CASE WOULD BE RE-ASSESSED. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 23 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS ADVERSE EVENT WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE, SO NO UPDATE IS REQUIRED. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR ACTICOAT¿ FLEX 3 REVEALS THAT IF THE DRESSING IS DRY OR ADHERED TO THE WOUND, MOISTEN, OR SOAK THE DRESSING TO ASSIST REMOVAL AND AVOID DISRUPTION OF THE HEALING WOUND. ALSO, THE ACTICOAT FLEX 3 IS COMPATIBLE WITH NEGATIVE PRESSURE WOUND THERAPY (NPWT) FOR A PERIOD OF UP TO 3 DAYS. WHEN IN USE WITH NPWT, THE WOUND FILLER MATERIAL SHOULD BE MOISTENED AND CHANGED ACCORDING TO MANUFACTURERS¿ INSTRUCTIONS. NO MANUFACTURING, PACKAGING, LABELLING, DESIGN, CONCERNS NOR ADVERSE TREND HAVE BEEN OBSERVED; THEREFORE, NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY. CORRECTED DATA.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4, D1, D4, D10, G3/G4

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TREATMENT OF A BREAST CANCER PATIENT, ONE (1) ACTICOAT 10X10CM CTN 12 AND VAC THERAPY WERE APPLIED ON (B)(6) 2023. THE ACTICOAT 10X10CM CTN 12 GOT STUCK IN THE WOUND AND IT WAS ABSORBED. THEY TRIED TO REMOVED THE PRODUCT ON (B)(6) 2023 BUT THE PROBLEM WAS NOT SOLVED. THE ITEM IS STILL STUCK ON THE BED AND WILL BE REMOVED SURGICALLY BY THE DOCTOR. NO OTHER COMPLICATION REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TREATMENT ONE (1) ACTICOAT FLEX3 10X10CM CTN OF 12 GOT STUCK IN THE PATIENT WOUND AND IT WAS ABSORBED. THE PROBLEM WAS NOT SOLVED. THE ITEM IS STILL STUCK ON THE BED AND WILL BE REMOVED SURGICALLY BY THE DOCTOR. NO OTHER COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155841 ACTICOAT FLEX3 10X10CM CTN OF 12 DRESSING, WOUND, DRUG FRO SMITH & NEPHEW MEDICAL LTD. 2229 00040565124810
    589694 ACTICOAT FLEX3 10X10CM CTN OF 12 DRESSING, WOUND, DRUG FRO SMITH & NEPHEW MEDICAL LTD. 2229 00040565124810

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female UNKN RENASYS TOUCH.