BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN OPSITE

    MDR report key: 10231041 · Received July 5, 2020

    Report

    Report Number
    8043484-2020-01511
    Event Type
    Injury
    Date Received
    July 5, 2020
    Date of Event
    January 1, 1901
    Report Date
    February 12, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE USED IN TREATMENT WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED, THEREFORE, A RELATIONSHIP WAS NOT ESTABLISHED BETWEEN THE DEVICE AND THE REPORTED EVENT. VISUAL AND FUNCTIONAL EVALUATIONS WERE NOT POSSIBLE WITHOUT PRODUCT AVAILABLE. REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AT THIS TIME WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. COMPLAINT HISTORY REVIEW FOR THREE PREVIOUS YEARS INDICATED SIMILAR ALLEGATIONS. INSTRUCTIONS FOR USE (IFU) CONTAIN RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. THE ASSOCIATED RISK FILES CONTAIN DETAILS RELATING TO HARM. HOWEVER, THE CLINICAL REVIEW HAS NOT ESTABLISHED A CAUSAL LINK. ADDITIONAL RMR IS NOT REQUIRED. ROOT CAUSE WAS NOT CONFIRMED. THERE IS NO EVIDENCE TO SUGGEST A DIRECT LINK BETWEEN PRODUCT AND REPORTED ALLEGATION. POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MIGHT BE: PATIENT SENSITIVITY, ALLERGIC REACTION, APPLICATION OR DRESSING DIFFICULTIES. SMITH AND NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THE REPORTED ALLEGATION. NO FURTHER INVESTIGATION REQUIRED AT THIS TIME. CLINICAL/MEDICAL INVESTIGATION WAS PERFORMED AND DETERMINED NO FURTHER ACTIONS WERE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS STUDY WAS APPROVED BY (B)(4) THE AIM OF THIS PROSPECTIVE (B)(4)STUDY WAS TO COMPARE HELICOLL® (ENCOLL CORP., (B)(4) USA), A TYPE I PURE COLLAGEN DRESSING, TO OPSITE® (SMITH & NEPHEW, USA) DRESSING AND TO SCARLET RED® (KENDALL HEALTHCARE, USA) DRESSING IN THE TREATMENT OF STANDARDIZED SPLIT THICKNESS SKIN GRAFT (STSG) DONOR SITES. PATIENTS WERE RANDOMIZED TO RECEIVE OPSITE, SCARLET RED OR HELICOLL AS A DONOR SITE DRESSING. THE PATIENTS STAYED IN THE HOSPITAL FOR 24 H AFTER THEIR SURGERY, WHERE DRESSINGS WERE CHANGED IF NECESSARY, AND ALL PATIENTS RECEIVED A STANDARD POST-OPERATIVE ORAL ANALGESIC AND DISCHARGED HOME TO BE SEEN IN THE CLINIC ON THE FIFTH POST-OPERATIVE DAY. THREE PATIENTS HAD YELLOW DISCHARGE UNDER THE WRINKLED OPSITE AND REQUIRED REMOVAL AND DAILY DRESSING CHANGE WITH ADAPTIC AND BACITRACIN. FOUR PATIENTS HAD PURULENT EXUDATES ASSOCIATED WITH REDNESS. PATIENTS WERE DIAGNOSED CLINICALLY TO HAVE DONOR SITE WOUND INFECTION, BUT NO CULTURES WERE OBTAINED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695162 UNKN OPSITE TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention