BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELFOAM

    MDR report key: 7435977 · Received April 17, 2018

    Report

    Report Number
    1810189-2018-00006
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Report Date
    October 15, 2017
    Manufacturer
    PFIZER, INC. (DEVICE)
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ATTACHMENT: [1810189-20180417135534_LIT.PDF].

    Description of Event or Problem · 0

    RECURRENT HEMORRHAGE 40 HOURS AFTER THE PROCEDURE [DEVICE MALFUNCTION] CASE DESCRIPTION: THIS IS A LITERATURE REPORT FROM THE SURGERY, 1976, 79 (4); 421-424 ENTITLED "GASTRIC INFARCTION AFTER . THERAPEUTIC EMBOLIZATION". THIS REPORTER REPORTED SIMILAR EVENTS FOR 3 PATIENTS. THIS IS 1ST OF 3 REPORTS. A PATIENT OF UNSPECIFIED AGE, ETHNICITY, AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR AN UNSPECIFIED INDICATION. MEDICAL HISTORY INCLUDED EMBOLIZATION FROM AN UNKNOWN DATE, AND UREMIA FROM AN UNKNOWN DATE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS PATIENT UNDERWENT SELECTIVE EMBOLIZATION WITH GELFOAM AS THE EMBOLIC AGENT. THERE WAS RECURRENT HEMORRHAGE 40 HOURS AFTER THE PROCEDURE. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN AND THE OUTCOME OF THE EVENT WAS UNKNOWN. COMMENT: BASED ON THE INFORMATION AVAILABLE, DIRECT, TESTABLE, FORENSIC, EMPIRICAL EVIDENCE WAS NOT PROVIDED TO RULE OUT THAT THE DEVICE MALFUNCTIONED (INCLUDING IMPACT TO THE FINISHED DEVICE) AND THE MALFUNCTION OF THE DEVICE OR A SIMILAR DEVICE MARKETED BY PFIZER WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THIS CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] RECURRENT HEMORRHAGE 40 HOURS AFTER THE PROCEDURE [DEVICE MALFUNCTION] , . CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE SURGERY, 1976, 79 (4); 421-424 ENTITLED "GASTRIC INFARCTION AFTER THERAPEUTIC EMBOLIZATION". THIS REPORTER REPORTED SIMILAR EVENTS FOR 3 PATIENTS. THIS IS 1ST OF 3 REPORTS. A PATIENT OF UNSPECIFIED AGE, ETHNICITY, AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR AN UNSPECIFIED INDICATION. MEDICAL HISTORY INCLUDED EMBOLIZATION FROM AN UNKNOWN DATE, AND UREMIA FROM AN UNKNOWN DATE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS PATIENT UNDERWENT SELECTIVE EMBOLIZATION WITH GELFOAM AS THE EMBOLIC AGENT. THERE WAS RECURRENT HEMORRHAGE 40 HOURS AFTER THE PROCEDURE. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN AND THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP (27APR2018): THIS IS A FOLLOW-UP SPONTANEOUS REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINT GROUP. (B)(4). CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. AS THE REPORTED DEFECT IS A PRODUCT MALFUNCTION THE COMPLAINT HAS BEEN ESCALATED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION IS NOT REQUIRED. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE INFORMATION AVAILABLE, DIRECT, TESTABLE, FORENSIC, EMPIRICAL EVIDENCE WAS NOT PROVIDED TO RULE OUT THAT THE DEVICE MALFUNCTIONED (INCLUDING IMPACT TO THE FINISHED DEVICE) AND THE MALFUNCTION OF THE DEVICE OR A SIMILAR DEVICE MARKETED BY PFIZER WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THIS CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] RECURRENT HEMORRHAGE 40 HOURS AFTER THE PROCEDURE [DEVICE MALFUNCTION] . CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE SURGERY, 1976, 79 (4); 421-424 ENTITLED "GASTRIC INFARCTION AFTER THERAPEUTIC EMBOLIZATION". THIS REPORTER REPORTED SIMILAR EVENTS FOR 3 PATIENTS. THIS IS 1ST OF 3 REPORTS. A PATIENT OF UNSPECIFIED AGE, ETHNICITY, AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR AN UNSPECIFIED INDICATION. MEDICAL HISTORY INCLUDED EMBOLIZATION FROM AN UNKNOWN DATE, AND UREMIA FROM AN UNKNOWN DATE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS PATIENT UNDERWENT SELECTIVE EMBOLIZATION WITH GELFOAM AS THE EMBOLIC AGENT. THERE WAS RECURRENT HEMORRHAGE 40 HOURS AFTER THE PROCEDURE. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN AND THE OUTCOME OF THE EVENT WAS UNKNOWN. , COMMENT: BASED ON THE INFORMATION AVAILABLE, DIRECT, TESTABLE, FORENSIC, EMPIRICAL EVIDENCE WAS NOT PROVIDED TO RULE OUT THAT THE DEVICE MALFUNCTIONED (INCLUDING IMPACT TO THE FINISHED DEVICE) AND THE MALFUNCTION OF THE DEVICE OR A SIMILAR DEVICE MARKETED BY PFIZER WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THIS CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280943 GELFOAM LMF PFIZER, INC. (DEVICE)

    Patients

    Seq Age Sex Outcome Treatment
    1