BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX

    MDR report key: 2340860 · Received November 11, 2011

    Report

    Report Number
    1000282279-2011-00004
    Event Type
    Injury
    Date Received
    November 11, 2011
    Date of Event
    July 30, 2011
    Report Date
    November 11, 2011
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    INM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) (SRVP QUALITY, REGULATORY & RISK MGMT GF HEALTH PRODUCTS, INC.) SPOKE WITH (B)(6) ON (B)(6) 2011. (B)(6), WHO WAS NOT EMPLOYED AT (B)(6) AT THE TIME, STATED THE CLAIMANT FELL OR LEANED BACK TO ONE SIDE OF THE SHOWER CHAIR. ON (B)(6) 2011, (B)(6) SPOKE WITH THE CLAIMANT'S ATTORNEY (B)(6), WHO EMAILED HER PICTURES OF THE PRODUCT AND STATED (B)(6) HAS POSSESSION OF THE "DEFECTIVE PRODUCT". GF HEALTH PRODUCTS, INC. HAS REQUESTED THE PRODUCT FROM (B)(6), WHERE THEY WILL HAVE IT EVALUATED BY AN INDEPENDENT THIRD PARTY. REVIEW OF THE PICTURES REFLECTED A BEND OR BUCKLING OF ONE LEG OF THE CHAIR, WHICH SUGGESTS THE DEFORMATION WAS DUE TO A SUDDEN DROP OR SHIFT OF THE CLAIMANT'S WEIGHT TO ONE REAR LEG. INITIAL FAILURE MODE ANALYSIS SHOWED THAT THIS WAS AN ISOLATED INCIDENT AND NOT A MALFUNCTION DUE TO MFG. GF HEALTH PRODUCTS, INC. NOTIFIED THE MFR ON (B)(6) 2011. GF HEALTH PRODUCTS, INC. IS STILL IN THE PROCESS OF INVESTIGATING THIS INCIDENT. DUE TO LIMITED DATA, THIS REPORT HAS LIMITED INFO. TESTING WAS PERFORMED ON THE DEVICE (B)(6) 2005 PRIOR TO MARKETING. TESTING WAS PERFORMED BY (B)(6). TEST PROCEDURES INCLUDED: DROP TEST, BACK STRENGTH TEST, AND MAXIMUM LOAD TEST. IT SHOULD BE NOTED THAT THIS PRODUCT WAS PRIVATE LABELED FOR GF HEALTH PRODUCTS, INC.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE CLAIMANT WAS ADMITTED TO (B)(6) MEDICAL CTR DUE TO AN ALLERGIC REACTION WHICH CAUSED SWELLING OF THE FEET. THE CLAIMANT WAS HELD OVERNIGHT FOR MONITORING. WHILE HOSPITALIZED, THE CLAIMANT WAS TAKING A SHOWER ON A HANDICAP CHAIR MFG BY GF HEALTH PRODUCTS, INC., WHEN THE CHAIR COLLAPSED CAUSING THE CLAIMANT TO FALL TO THE GROUND. THE CLAIMANT'S ATTORNEY STATED THE PT WAS WEIGHED AFTER THE INCIDENT OCCURRED. HE ALSO STATED HIS CLIENT WEIGHED (B)(6) AT THE TIME OF THE INCIDENT. THERE WAS CONFLICTING INFO IN THE PETITION PROVIDED TO GF HEALTH PRODUCTS, INC. IN SOME PORTIONS OF THE PETITION THE CLAIMANT IS REFERRED TO AS A MALE, IN OTHERS A FEMALE. THERE WAS ALSO DIFFERENCES IN THE REPORTED INJURIES. SOME PORTIONS STATE THE CLAIMANT ACQUIRED BACK INJURIES, IN OTHERS IT IS STATED THEY SUSTAINED INJURIES TO THEIR INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX BATH SET INM FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. 7921A-4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other