BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 3035821 · Received March 22, 2013

    Report

    Report Number
    1024404-2013-00001
    Event Type
    Other
    Date Received
    March 22, 2013
    Product Code
    CCX
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) LOT NUMBER 1284003. MERCURY MEDICAL RECEIVED FDA LETTER POST MARKED (B)(6) 2013. A MERCURY MEDICAL SALES REPRESENTATIVE (MMSR) WENT ON-SITE TO COLLECT THE IDENTIFIED FACE-CRADLE CUSHION. HE DISCUSSED THE INJURY WITH THE CLINICIANS ASSOCIATED WITH THE CASE. PATIENT INJURY PHOTOS WERE OBTAINED ON (B)(4) 2013. THE INVESTIGATING QE CONFIRMED ERYTHEMA WAS VISIBLE ON THE PATIENT'S CHIN AND FOREHEAD. FURTHER PATIENT REPORTS STATED THE CHIN AREA REDNESS DEVELOPED INTO A PRESSURE SORE WITH FLUID DISCHARGE. UPON A SITE VISIT, THE MMSR WAS INFORMED THAT A PLASTIC SURGEON EXAMINED THE PRESSURE SORE AND INDICATED IT WOULD HEAL ON ITS OWN. LATER REPORTS STATED THAT THE PATIENT'S CHIN SKIN WAS HEALING. THE MEDWATCH REPORTER ATTRIBUTED THE ROOT CAUSE TO A PRONE PATIENT RESTING ON HARD PLASTIC BARS UNDERNEATH THE FACE-CRADLE CUSHION. REVIEW OF MEDWATCH REPORTS ON AN ANALOGOUS PRODUCT, DUPACO PRONEVIEW, LISTS NUMEROUS PRESSURE ULCER REPORTS ON PATIENT CHEEKS/CHINS WITH A CONTOUR FOAM DEVICE LACKING ANY HARD PLASTIC RIBS. THEREFORE, IT IS LIKELY THAT THE UPPER AND LOWER RIBS ON THE FACE CRADLE DEVICE ARE THE ROOT CAUSE OF THE REPORTED BROW REDNESS AND THE CHIN PRESSURE SORE. ADDITIONALLY, THE PRONEVIEW FOAM EXTENDS BELOW THE CHIN AREA BUT THIS FEATURE DOESN'T ELIMINATE CHIN INJURY REPORTS. AFTER REVIEWING THE INFORMATION, A MEDICAL PROFESSIONAL STATED THE REPORTED INJURY WAS MINOR, TEMPORARY AND THAT SOME REDNESS IS EXPECTED POST PRONE POSITIONING. THE OPINION ALSO STATED KNOWN ROOT CAUSES FOR PRONE DEVICE PRESSURE SORES, INCLUDING: FAILURE TO MAINTAIN THE PATIENT IN A NEUTRAL POSITION WHILE THE DEVICE, LENGTH OF PROCEDURE, SKIN COMPRESSION WHILE UNDER GENERAL ANESTHESIA, ABILITY OF THE CLINICIAN TO READJUST PATIENT POSITION DURING THE PROCEDURE AND PATIENT FACTORS SUCH AS AGE, WEIGHT, PERSPIRATION, BIOMETRICS, ETC. THE CURRENT FACE-CRADLE DFU WARNS THE CLINICIAN TO FREQUENTLY MONITOR THE PATIENT'S NECK, HEAD, EYES, NOSE AND MOUTH TO ENSURE THAT A SAFE POSITION IS MAINTAINED. IN ORDER TO FURTHER REDUCE THE LIKELIHOOD OF SKIN ABRASIONS OR PRESSURE ULCERS, THE DFU WILL BE UPDATED TO RECOMMEND THAT CLINICIANS PERIODICALLY REPOSITION THE PATIENT'S HEAD AND DIRECTED BY THEIR DEPARTMENT MANUAL OR EVERY TWO HOURS WHERE PRACTICABLE AS STANDARD CLINICAL GUIDELINES SUGGEST.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119776 NONE CCX

    Patients

    Seq Age Sex Outcome Treatment
    1