BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELFOAM

    MDR report key: 16823083 · Received April 27, 2023

    Report

    Report Number
    1810189-2023-00083
    Event Type
    Injury
    Date Received
    April 27, 2023
    Report Date
    April 13, 2023
    Manufacturer
    PFIZER, INC. (DEVICE)
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM], GELFOAM FOR PARTIAL SPLENIC EMBOLIZATION [OFF LABEL USE], GELFOAM FOR PARTIAL SPLENIC EMBOLIZATION [DEVICE USE ISSUE], BACTERIAL PERITONITIS [PERITONITIS BACTERIAL]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "CLINICAL APPLICATION OF KELP MICRO GELATION (KMG) IN PARTIAL SPLENIC EMBOLIZATION", EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 2018; VOL:22, PGS:1776-1781. A PATIENT (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR SPLENIC ARTERY EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "HYPERSPLENISM" (UNSPECIFIED IF ONGOING); "SPLEEN ENLARGEMENT" (UNSPECIFIED IF ONGOING); "LIVER CIRRHOSIS" (UNSPECIFIED IF ONGOING); "LEUKOPENIA" (UNSPECIFIED IF ONGOING); "THROMBOCYTOPENIA" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "GELFOAM FOR PARTIAL SPLENIC EMBOLIZATION"; PERITONITIS BACTERIAL (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "BACTERIAL PERITONITIS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: UNKNOWN RESULTS; MAGNETIC RESONANCE IMAGING: UNKNOWN RESULTS; PLATELET COUNT: UNKNOWN RESULTS; RED BLOOD CELL COUNT: UNKNOWN RESULTS; WHITE BLOOD CELL COUNT: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, DEVICE USE ISSUE, PERITONITIS BACTERIAL. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (06DEC2023): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY COMPLAINT GROUP PROVIDING THE FOLLOWING INVESTIGATION RESULTS: CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE AVAILABLE INFORMATION, A POSSIBLE CONTRIBUTORY ROLE OF SUBJECT PRODUCT, ABSORBABLE GELATIN, CANNOT BE EXCLUDED FOR THE REPORTED EVENT OF BACTERIAL PERITONITIS, BASED ON TEMPORAL RELATIONSHIP. HOWEVER, THE REPORTED EVENT MAY POSSIBLY REPRESENT A POTENTIAL COMPLICATION OF THE SURGICAL PROCEDURE OF PARTIAL SPLENIC EMBOLIZATION. THERE IS LIMITED INFORMATION PROVIDED IN THIS REPORT. THIS CASE WILL BE REASSESSED UPON RECEIPT OF FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM]. GELFOAM FOR PARTIAL SPLENIC EMBOLIZATION [OFF LABEL USE]. BACTERIAL PERITONITIS [PERITONITIS BACTERIAL]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "CLINICAL APPLICATION OF KELP MICRO GELATION (KMG) IN PARTIAL SPLENIC EMBOLIZATION", EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 2018; VOL:22, PGS:1776-1781. A PATIENT (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR SPLENIC ARTERY EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "HYPERSPLENISM" (UNSPECIFIED IF ONGOING); "SPLEEN ENLARGEMENT" (UNSPECIFIED IF ONGOING); "LIVER CIRRHOSIS" (UNSPECIFIED IF ONGOING); "LEUKOPENIA" (UNSPECIFIED IF ONGOING); "THROMBOCYTOPENIA" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "GELFOAM FOR PARTIAL SPLENIC EMBOLIZATION"; PERITONITIS BACTERIAL (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "BACTERIAL PERITONITIS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: UNKNOWN RESULTS; MAGNETIC RESONANCE IMAGING: UNKNOWN RESULTS; PLATELET COUNT: UNKNOWN RESULTS; RED BLOOD CELL COUNT: UNKNOWN RESULTS; WHITE BLOOD CELL COUNT: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, PERITONITIS BACTERIAL. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE AVAILABLE INFORMATION, A POSSIBLE CONTRIBUTORY ROLE OF SUBJECT PRODUCT, ABSORBABLE GELATIN, CANNOT BE EXCLUDED FOR THE REPORTED EVENT OF BACTERIAL PERITONITIS, BASED ON TEMPORAL RELATIONSHIP. HOWEVER, THE REPORTED EVENT MAY POSSIBLY REPRESENT A POTENTIAL COMPLICATION OF THE SURGICAL PROCEDURE OF PARTIAL SPLENIC EMBOLIZATION. THERE IS LIMITED INFORMATION PROVIDED IN THIS REPORT. THIS CASE WILL BE REASSESSED UPON RECEIPT OF FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558437 GELFOAM SPONGE, STERILE; CLASS III LMF PFIZER, INC. (DEVICE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R