BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORBABLE GELATIN

    MDR report key: 23657374 · Received November 26, 2025

    Report

    Report Number
    1810189-2025-00031
    Event Type
    Injury
    Date Received
    November 26, 2025
    Report Date
    November 17, 2025
    Manufacturer
    PFIZER, INC.
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON [(B)(6) 2026] FOR [ABSORBABLE GELATIN]: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL 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]. TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED [OFF LABEL USE], TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED [DEVICE USE ISSUE], HAD RE-HAEMORRHAGE AND UNDERWENT PERIHEPATIC PACKING (PHP) [HEPATIC HAEMORRHAGE], ABDOMINAL COMPARTMENT SYNDROME [ABDOMINAL COMPARTMENT SYNDROME], HEPATIC INFARCTION AND ABSCESS FORMATION [HEPATIC INFARCTION], HEPATIC INFARCTION AND ABSCESS FORMATION [LIVER ABSCESS], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF CONTINUOUS AND STEPWISE DAMAGE CONTROL STRATEGIES FOR LIVER INJURY - FROM TAE, PHP, OAM TO RESECTIONAL DEBRIDEMENT", THE 53RD ANNUAL MEETING OF THE JAPANESE ASSOCIATION FOR ACUTE MEDICINE, 2025; VOL:53RD, PGS:1367. A MALE PATIENT IN HIS 50'S RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "CIRRHOSIS ALCOHOLIC" (UNSPECIFIED IF ONGOING); "THORACOABDOMINAL BLUNT TRAUMA" (UNSPECIFIED IF ONGOING); "VEHICLE ACCIDENT" (UNSPECIFIED IF ONGOING); "POSTHEPATIC SEGMENTAL INJURY AND HAEMORRHAGE" (UNSPECIFIED IF ONGOING); "POSTHEPATIC SEGMENTAL INJURY AND HAEMORRHAGE" (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 "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED"; HEPATIC HAEMORRHAGE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "HAD RE-HAEMORRHAGE AND UNDERWENT PERIHEPATIC PACKING (PHP)"; ABDOMINAL COMPARTMENT SYNDROME (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN"; HEPATIC INFARCTION (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", LIVER ABSCESS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED" AND ALL DESCRIBED AS "HEPATIC INFARCTION AND ABSCESS FORMATION". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: POSTHEPATIC SEGMENTAL INJURY AND HAEMORRHAGE, NOTES: THE JAPANESE ASSOCIATION FOR THE SURGERY OF TRAUMA CLASSIFICATION TYPE IIIB. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF HEPATIC HAEMORRHAGE, ABDOMINAL COMPARTMENT SYNDROME, LIVER ABSCESS. CLINICAL COURSE: THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WITH THORACOABDOMINAL BLUNT TRAUMA DUE TO A SINGLE VEHICLE ACCIDENT OF A NORMAL PASSENGER CAR. CT SHOWED POSTHEPATIC SEGMENTAL INJURY AND HAEMORRHAGE OF THE JAPANESE ASSOCIATION FOR THE SURGERY OF TRAUMA CLASSIFICATION TYPE IIIB, AND TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED. EIGHT HOURS AFTER TAE, THE PATIENT HAD RE-HAEMORRHAGE AND UNDERWENT PERIHEPATIC PACKING (PHP). SUBSEQUENTLY, OPEN ABDOMEN MANAGEMENT (OAM) WAS PERFORMED FOR ABDOMINAL COMPARTMENT SYNDROME. PLANNED LAPAROTOMY WAS PERFORMED AGAIN 40 HOURS AFTER PHP, AND RESECTIONAL DEBRIDEMENT WAS PERFORMED. POSTOPERATIVELY, HEPATIC INFARCTION AND ABSCESS FORMATION WERE OBSERVED, WHICH WAS RESOLVED WITH PERCUTANEOUS DRAINAGE, AND HE WAS DISCHARGED ON DAY 78 OF ILLNESS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON [07JAN2026] FOR [ABSORBABLE GELATIN]: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL 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. THE REPORTER CONSIDERED "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED", "HAD RE-HAEMORRHAGE AND UNDERWENT PERIHEPATIC PACKING (PHP)", "ABDOMINAL COMPARTMENT SYNDROME" AND "HEPATIC INFARCTION AND ABSCESS FORMATION" ASSOCIATED TO ABSORBABLE GELATIN. CAUSALITY FOR "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED", "HAD RE-HAEMORRHAGE AND UNDERWENT PERIHEPATIC PACKING (PHP)", "ABDOMINAL COMPARTMENT SYNDROME" AND "HEPATIC INFARCTION AND ABSCESS FORMATION" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (07JAN2026): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: THE EVENTS HEPATIC HAEMORRHAGE, ABDOMINAL COMPARTMENT SYNDROME, HEPATIC INFARCTION, LIVER ABSCESS ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM). THE EVENT ABDOMINAL COMPARTMENT SYNDROME WAS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM]. TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED [OFF LABEL USE], TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED [DEVICE USE ISSUE], HAD RE-HAEMORRHAGE AND UNDERWENT PERIHEPATIC PACKING (PHP) [HEPATIC HAEMORRHAGE], ABDOMINAL COMPARTMENT SYNDROME [ABDOMINAL COMPARTMENT SYNDROME], HEPATIC INFARCTION AND ABSCESS FORMATION [HEPATIC INFARCTION], HEPATIC INFARCTION AND ABSCESS FORMATION [LIVER ABSCESS], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF CONTINUOUS AND STEPWISE DAMAGE CONTROL STRATEGIES FOR LIVER INJURY - FROM TAE, PHP, OAM TO RESECTIONAL DEBRIDEMENT", THE 53RD ANNUAL MEETING OF THE JAPANESE ASSOCIATION FOR ACUTE MEDICINE, 2025; VOL:53RD, PGS:1367. A MALE PATIENT IN HIS 50'S RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "CIRRHOSIS ALCOHOLIC" (UNSPECIFIED IF ONGOING); "THORACOABDOMINAL BLUNT TRAUMA" (UNSPECIFIED IF ONGOING); "VEHICLE ACCIDENT" (UNSPECIFIED IF ONGOING); "POSTHEPATIC SEGMENTAL INJURY AND HAEMORRHAGE" (UNSPECIFIED IF ONGOING); "POSTHEPATIC SEGMENTAL INJURY AND HAEMORRHAGE" (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 "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED"; HEPATIC HAEMORRHAGE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "HAD RE-HAEMORRHAGE AND UNDERWENT PERIHEPATIC PACKING (PHP)"; ABDOMINAL COMPARTMENT SYNDROME (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN"; HEPATIC INFARCTION (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", LIVER ABSCESS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED" AND ALL DESCRIBED AS "HEPATIC INFARCTION AND ABSCESS FORMATION". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: POSTHEPATIC SEGMENTAL INJURY AND HAEMORRHAGE, NOTES: THE JAPANESE ASSOCIATION FOR THE SURGERY OF TRAUMA CLASSIFICATION TYPE IIIB. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF HEPATIC HAEMORRHAGE, ABDOMINAL COMPARTMENT SYNDROME, LIVER ABSCESS. CLINICAL COURSE: THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WITH THORACOABDOMINAL BLUNT TRAUMA DUE TO A SINGLE VEHICLE ACCIDENT OF A NORMAL PASSENGER CAR. CT SHOWED POSTHEPATIC SEGMENTAL INJURY AND HAEMORRHAGE OF THE JAPANESE ASSOCIATION FOR THE SURGERY OF TRAUMA CLASSIFICATION TYPE IIIB, AND TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED. EIGHT HOURS AFTER TAE, THE PATIENT HAD RE-HAEMORRHAGE AND UNDERWENT PERIHEPATIC PACKING (PHP). SUBSEQUENTLY, OPEN ABDOMEN MANAGEMENT (OAM) WAS PERFORMED FOR ABDOMINAL COMPARTMENT SYNDROME. PLANNED LAPAROTOMY WAS PERFORMED AGAIN 40 HOURS AFTER PHP, AND RESECTIONAL DEBRIDEMENT WAS PERFORMED. POSTOPERATIVELY, HEPATIC INFARCTION AND ABSCESS FORMATION WERE OBSERVED, WHICH WAS RESOLVED WITH PERCUTANEOUS DRAINAGE, AND HE WAS DISCHARGED ON DAY 78 OF ILLNESS. CAUSALITY FOR "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING GELATIN SPONGES WAS PERFORMED", "HAD RE-HAEMORRHAGE AND UNDERWENT PERIHEPATIC PACKING (PHP)", "ABDOMINAL COMPARTMENT SYNDROME" AND "HEPATIC INFARCTION AND ABSCESS FORMATION" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION)., COMMENT: THE EVENTS HEPATIC HAEMORRHAGE, ABDOMINAL COMPARTMENT SYNDROME, HEPATIC INFARCTION, LIVER ABSCESS ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM). THE EVENT ABDOMINAL COMPARTMENT SYNDROME WAS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030253 ABSORBABLE GELATIN SPONGE, STERILE; CLASS III LMF PFIZER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other| R