BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO QUADTRO SELECT HIGH PROFILE CUSHION

    MDR report key: 11603091 · Received April 1, 2021

    Report

    Report Number
    3008630266-2021-00006
    Event Type
    Injury
    Date Received
    April 1, 2021
    Report Date
    April 1, 2021
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER STATED THAT THE END USER HAS A PRESSURE INJURY, BUT ROHO, INC. HAS NO INFRMATION AVAILABLE TO MAKE A DETERMINATION OF THE EXTENT OF THE ALLEGED INJURY. THE CUSHION WAS NOT RETURNED TO ROHO, INC., SO AN EVALUATION COULD NOT BE PERFORMED. THE INITIAL CALLER DID NOT PROVIDE A CONTACT PHONE NUMBET SINCE SHE WAS CALLING ON BEHALF OF THE END USER. THE END USER'S ADDRESS WAS PROVIDED AND ROHO, INC. SENT TWO LETTERS REQUESTING THE CUSTOMER CALL BACK FOR ADDITIONAL INVESTIGATION COULD BE CONDUCTED, BUT ROHO, INC. HAS NOT BEEN CONTACTED BY THE END USER. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN OCCUPATIONAL THERAPIST FROM A WHEELCHAIR AND SEATING CLINIC CALLED ON AN END USER'S BEHALF. SHE SAID HIS MOST RECENT CUSHION WAS PURCHASED IN (B)(6) OF 2019. IT WAS RELAYED TO HER THAT ONE OF THE BACK QUADRATS WASN'T STAYING INFLATED AND THE END USER HAS A PRESSURE SORE ON THE PART OF HIS BODY THAT SITS ON THAT PART OF THE CUSHION. SHE SAID SHE HADN'T SEEN HIM IN HER CLINIC SINCE 2018 AND HE HAD A WORKING CUSHION AT THAT TIME. SHE SAID SHE WAS CALLING FOR HIM AS HE WAS HAVING TROUBLE RESOLVING THE ISSUE HIMSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499193 ROHO QUADTRO SELECT HIGH PROFILE CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. QS1111C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other WHEELCHAIR