BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN OPSITE

    MDR report key: 10769241 · Received November 2, 2020

    Report

    Report Number
    8043484-2020-03476
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    January 1, 1901
    Report Date
    February 2, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES USED IN TREATMENT HAVE NOT BEEN RETURNED FOR EVALUATION THEREFORE WE CANNOT ESTABLISH A RELATIONSHIP BETWEEN THE DEVICES AND THE REPORTED EVENTS. MEDICAL REVIEW CONCLUDED, THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED AT THIS TIME. PROBABLE CAUSE FOR THE REPORTED FAILURE INCLUDES DRESSINGS LEFT IN PLACE BEYOND THE PRESCRIBED USE. THE INSTRUCTIONS FOR USE PROVIDE COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE. THE ASSOCIATED RISK FILES CONTAIN DETAILS RELATING TO HARM, HOWEVER THE CLINICAL REVIEW HAS NOT ESTABLISHED A CAUSAL LINK. ADDITIONAL RMR IS NOT REQUIRED. A REVIEW OF THE BATCH MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO PART OR LOT NUMBERS WERE PROVIDED, HOWEVER, THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. THE COMPLAINT HISTORY FILE CONTAINS FURTHER INSTANCES OF THE REPORTED EVENTS, HOWEVER THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY AT THIS STAGE. 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 · 1

    THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IN THE PAPER " PLASTIC AND RECONSTRUCTIVE SURGERY GLOBAL OPEN 2020- NEGATIVE PRESSURE WOUND THERAPY REDUCES WOUND BREAKDOWN AND IMPLANT LOSS IN PREPECTORAL BREAST RECONSTRUCTION" THE AUTHORS OF THE STUDY REPORTED CASES OF WOUND BREAKDOWN WHICH WERE TREATED WITH A CHANGE IN DRESSING MANAGEMENT PLAN. IN THE GROUP OF PATIENTS USING OPSITE, 3 IMPLANTS WERE SAVED WHILE 7 CASES LED TO IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237566 UNKN OPSITE TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R