BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN OPSITE

    MDR report key: 10231128 · Received July 5, 2020

    Report

    Report Number
    8043484-2020-01571
    Event Type
    Injury
    Date Received
    July 5, 2020
    Report Date
    February 10, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    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. ROOT CAUSE WAS NOT CONFIRMED. THERE IS NO EVIDENCE TO SUGGEST A DIRECT LINK BETWEEN PRODUCT AND REPORTED ALLEGATION. REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. COMPLAINT HISTORY REVIEW FOR THREE PREVIOUS YEARS INDICATED SIMILAR ALLEGATIONS. INSTRUCTIONS FOR USE (IFU) CONTAIN RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. RISK MANAGEMENT FILES CONTAIN THE REPORTED ALLEGATION. NO UPDATE REQUIRED. CLINICAL/MEDICAL INVESTIGATION WAS PERFORMED AND DETERMINED NO FURTHER ACTIONS REQUIRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS STUDY WAS APPROVED BY THE INSTITUTIONAL REVIEW BOARD OF THE UNIVERSITY OF (B)(6) ALONG WITH THE INSTITUTIONAL IRB APPROVAL AT (B)(6). THE AIM OF THIS PROSPECTIVE RANDOMIZED CONTROLLED STUDY WAS TO COMPARE HELICOLL® (ENCOLL CORP., FREMONT, CA 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. FLUID COLLECTION WAS SEEN IN ALL TEN OPSITE CASES, CAUSING SEVEN OUTPATIENT VISITS DUE TO LEAKAGE FROM THE EDGES OF THE OPSITE DRESSING REQUIRING DRESSING CHANGE, FIVE PATIENTS REQUIRED A SMALL FENESTRATION OF THE OPSITE TO DRAIN THE COLLECTING FLUID AND A NEW FILM WAS USED TO REINFORCE THE REMAINING PARTS OF THE ORIGINAL DRESSING FOLLOWED BY A SECONDARY ABSORBENT DRESSING TO PREVENT CONSTANT LEAKING AND 8 PATIENTS IN THE OPSITE GROUP REPORTED PAIN, IT STARTED ON THE FOURTH OR FIFTH POST-OPERATIVE DAY DUE TO MACERATION OF THE WOUND ATTRIBUTED TO FLUID COLLECTION BENEATH THE OPSITE. 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
    695101 UNKN OPSITE TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other