BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKN OPSITE POST OP

    MDR report key: 13619754 · Received February 28, 2022

    Report

    Report Number
    8043484-2022-00081
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    August 16, 2019
    Report Date
    May 13, 2022
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). TOTTY, J. P., HITCHMAN, L. H., CAI, P. L., HARWOOD, A. E., WALLACE, T., CARRADICE, D., ... & CHETTER, I. C. (2019). A PILOT FEASIBILITY RANDOMISED CLINICAL TRIAL COMPARING DIALKYLCARBAMOYLCHLORIDE-COATED DRESSINGS VERSUS STANDARD CARE FOR THE PRIMARY PREVENTION OF SURGICAL SITE INFECTION. INTERNATIONAL WOUND JOURNAL, 16(4), 883-890. DOI: 10.1111/IWJ.13113.

    Additional Manufacturer Narrative · 0

    REASSESSMENT OF THIS INCIDENT FOUND IT NOT TO FULFILL REPORTING CRITERIA. LOCAL INFECTION AT THE APPLICATION AND/OR SURGICAL SITE THAT RESOLVES ON ITS OWN OR WITH MINOR MEDICAL INTERVENTION DOES NOT REPRESENT A SERIOUS INJURY OR PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE AND IS CONSIDERED NOT REPORTABLE PURSUANT TO 21 CFR §803. CORRECTED H6

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "A PILOT FEASIBILITY RANDOMISED CLINICAL TRIAL COMPARING DIALKYLCARBAMOYLCHLORIDE-COATED DRESSINGS VERSUS STANDARD CARE FOR THE PRIMARY PREVENTION OF SURGICAL SITE INFECTION", 70 PATIENTS WERE TREATED WITH THE OPSITE POST OP DRESSING AFTER AN UNSPECIFIED SURGICAL INTERVENTION. 18 OUT OF THOSE 70 PATIENTS SUFFERED FROM A SURGICAL SITE INFECTION. IT IS UNKNOWN IF/HOW THE INFECTIONS WERE TREATED. THE OUTCOME OF THE PATIENTS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714191 UNKN OPSITE POST OP TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other