BEUDAMED
    FDA Adverse Event Summary report: N

    ABDOMINAL BINDER

    MDR report key: 3231125 · Received July 16, 2013

    Report

    Report Number
    3231125
    Date Received
    July 16, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 16, 2013
    Manufacturer
    DEROYAL INDUSTRIES INC.
    Product Code
    FSD
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED RED, NON-RAISED, RASH FROM ABDOMINAL BINDER THAT WAS USED POST C-SECTION. I SPOKE WITH THE CLINICAL LEADER OF MOTHER BABY UNIT AND LABOR AND DELIVERY AND THEY BOTH STATED THERE HAS BEEN NOTHING DIFFERENT IN EITHER PRODUCTS OR PROCEDURES TO WHICH THEY CAN ATTRIBUTE THIS TYPE OF EVENT (BINDERS CAUSING A RASH). THERE HAS BEEN NO CHANGE IN L&D TO THE SKIN PREP, DRESSINGS, OR THE OR PACKS. THE ABDOMINAL BINDERS ARE PLACED ON DRY SKIN IN LABOR AND DELIVERY.THIS FACILITY HAS HAD MORE THAN 10 SIMILAR EVENTS WITH THIS PRODUCT IN THE LAST 5 MONTHS. PRODUCT STATES LATEX FREE. THE FACILITY REPORTS THIS TYPE OF REACTION HAS BEEN SEEN IN PATIENTS WITH C-SECTIONS AS WELL AS VAGINAL DELIVERIES; THUS, STAFF DOES NOT BELIEVE THAT THERE IS A REACTION TO THE SKIN PREP USED FOR C-SECTION DELIVERIES BECAUSE THE PREP IS NOT USED IN A VAGINAL DELIVERY. ALSO, STAFF HAS STATED IN PREVIOUS INCIDENTS THAT THE RASH OCCURS ON AREAS WHICH DOES NOT HAVE THE SKIN PREP BUT DOES HAVE CONTACT WITH THE BINDER. PATIENTS WITH AND WITHOUT KNOWN ALLERGIES HAVE BEEN AFFECTED. THE MANUFACTURER HAS BEEN NOTIFIED. THEY ARE UNAWARE OF ANY OTHER COMPLAINTS LIKE THIS.WE CHECKED WITH OUR SURGICAL UNIT BECAUSE THEY USE QUITE A FEW ABDOMINAL BINDERS AND THEY HAVE NOT HEARD OF ANY CONCERNS REGARDING RASH. PATIENTS IN THE SURGICAL UNIT WOULD HAVE SIMILAR USE OF THIS DEVICE. ALSO, THERE ARE PATIENTS IN THE SURGICAL UNIT BOTH WHO HAVE AND WHO HAVE NOT HAD EXPOSURE TO THE SAME BRAND OF SKIN PREP AS THE PATIENTS ON THE OTHER NURSING UNIT. THE STORAGE PROCEDURE/PROCESS FOR BOTH NURSING UNITS IS IDENTICAL: STORAGE AND TRANSPORTATION OF THE DEVICES ARE NOT BELIEVED TO BE CONTRIBUTING FACTORS IN THESE EVENTS.======================MANUFACTURER RESPONSE FOR ABDOMINAL BINDER MEDIUM/LARGE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================I SPOKE WITH THE MANUFACTURER'S REP AND THEY STATED THEY WOULD SEND PACKAGING LABEL VIA EMAIL TO RETURN FOR INVESTIGATION. I REMINDED THEM THAT I STILL HAD NOT RECEIVED PACKAGING LABELS FOR THE THREE OTHER ABDOMINAL BINDERS I CALLED ABOUT LAST WEEK. THEY PLAN TO SEND A LABEL SO I CAN RETURN ALL FOUR BINDERS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ABDOMINAL INCISIONAL SUPPORT POST C-SECTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328495 ABDOMINAL BINDER BINDER, ABDOMINAL FSD DEROYAL INDUSTRIES INC. * 31048058

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR OTHER| SKIN PREP