BEUDAMED
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    Morphic Medical, Inc.

    Manufacturer
    🇺🇸 United States

    Morphic Medical Inc

    FDA registration
    Morphic Medical Inc·1 product·🇺🇸 United States

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

    SAPPHIRE EPIDURAL INFUSION PUMP SPANISH

    FDA Adverse Event
    Malfunction ·Q CORE MEDICAL LTD.·Product code FRN·May 16, 2018

    PERFUSOR®

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·August 22, 2024

    PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).

    FDA Enforcement
    Class II ·Terminated·Flowonix Medical, Inc.·July 26, 2017

    SAPPHIRE M.T INFUSION PUMP- US

    FDA Adverse Event
    Malfunction ·Q CORE MEDICAL LTD.·Product code FRN·April 4, 2019

    INFUSOMAT

    FDA Adverse Event
    Malfunction ·B.BRAUN MELSUNGEN AG·Product code FRN·February 17, 2021

    Q2 MULTIPORT ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·QUEST MEDICAL, INC.·Product code FPA·September 6, 2013

    PERFUSOR SPACE

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·June 15, 2023

    PERFUSOR SPACE ACM-KIT

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·August 25, 2016

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·March 21, 2016

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2016

    COMPANION 5

    FDA Adverse Event
    Injury ·CAIRE INC.·Product code CAW·February 20, 2026

    EASYPUMP II LT

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·October 26, 2012

    AMBIT PCA AMBULATORY PUMP

    FDA Adverse Event
    Death ·AVANOS MEDICAL INC.·Product code MEA·October 18, 2023

    DORSAL COLUMN STIMULATOR AND OCTRODE EXTENSION LEAD

    FDA Adverse Event
    Injury ·QUEST MEDICAL, INC.·Product code GZB·February 28, 1996

    INFUSOMAT SPACE - US VERSION

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·April 4, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·June 27, 2018

    INFUSOMAT®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FRN·December 5, 2024