BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT ADHESIVE CREAM, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLULO

    MDR report key: 1760390 · Received July 2, 2010

    Report

    Report Number
    9617667-2010-00004
    Event Type
    Injury
    Date Received
    July 2, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    PROCTER & GAMBLE MFG. GMBH
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER, THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    ACCIDENTAL INGESTION OF A TUBE OF FIXODENT [ACCIDENTAL EXPOSURE]. WRONG ROUTE OF ADMINISTRATION (FIXODENT - ACCIDENTAL INGESTION) [INCORRECT ROUTE OF DRUG ADMINISTRATION]. NO ADVERSE EVENTS WERE REPORTED [NO ADVERSE EVENT]. CASE DESCRIPTION: A NURSE AT THE (B)(6) REPORTED THAT A MALE CONSUMER OF AGE (B)(6) ACCIDENTALLY INGESTED AN UNSPECIFIED QUANTITY OF FIXODENT CREAM, VERSION UNKNOWN ON UNSPECIFIED DATE(S). THE CONSUMER UNDERWENT ASPIRATION OF THE DIGESTIVE TRACT AND REMAINED IN THE HOSPITAL FOR OBSERVATION. NO ADVERSE EVENTS WERE REPORTED. MEDICAL HISTORY: NO INFORMATION WAS PROVIDED. CONCOMITANT MEDICATION: NO INFORMATION WAS PROVIDED. THE OUTCOME OF THE CASE WAS: NO SYMPTOMS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2010, THE INITIAL REPORTER WAS RECONTACTED. SHE STATED THAT ON (B)(6) 2010 A MALE CONSUMER OF (B)(6), ACCIDENTALLY INGESTED AN UNKNOWN QUANTITY OF AN UNSPECIFIED BRAND OF DENTURE ADHESIVE. THE CONSUMER UNDERWENT ASPIRATION OF THE DIGESTIVE TRACT AND WAS PUT UNDER MEDICAL SURVEILLANCE. HE REMAINED IN THE HOSPITAL, BUT WAS NOT IN ANY DANGER AND WOULD BE RELEASED SHORTLY. THE REPORTER STATED THAT THE CONSUMER SUFFERED FROM DEMENTIA WHICH MIGHT EXPLAIN IS MISUSE OF THE PRODUCT INVOLVED. SHE CONFIRMED THAT SHE WAS UNABLE TO NAME THE SPECIFIC BRAND OF DENTURE ADHESIVE INGESTED BY THE CONSUMER. MEDICAL HISTORY: DEMENTIA. CONCOMITANT MEDICATION: NO INFORMATION WAS PROVIDED. THE OUTCOME OF THE CASE WAS: NO SYMPTOMS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2010, A COMPLETED DRUG EXPERIENCE FORM WAS RECEIVED FROM A DOCTOR IN THE (B)(6) (SAME HOSPITAL AND DEPARTMENT AS THE INITIAL REPORTER). HE CONFIRMED THAT THE MALE CONSUMER ((B)(6)) CUT OPEN AND INGESTED THE TOTALITY OF A TUBE OF FIXODENT ADHESIVE CREAM, VERSION UNKNOWN. HE WAS HOSPITALIZED ON (B)(6) 2010 AND WAS ASPIRATED WITH DIFFICULTY USING A CATHETER AND A FIBROSCOPE. THE SEVERITY OF THE EVENT WAS ASSESSED AS "SEVERE" BY THE REPORTER. MEDICAL HISTORY: DEMENTIA AND PARKINSON'S DISEASE. CONCOMITANT MEDICATION: NO INFORMATION WAS PROVIDED. THE OUTCOME OF THE CASE WAS: NO SYMPTOMS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2010, THE DOCTOR WAS RE-CONTACTED BY P&G TO RESOLVE DISCREPANCIES BETWEEN THE REPORTS RECEIVED FROM THE DOCTOR AND THE INITIAL REPORTER (NURSE). THE DOCTOR AGAIN CONFIRMED THAT THE PRODUCT WAS FIXODENT ADHESIVE CREAM, VERSION UNKNOWN. HE STATED THAT ALTHOUGH HE HAD NOT SEEN THE PRODUCT, IT WAS REPORTED TO HIM TO BE FIXODENT BY MEMBERS OF THE CONSUMER'S FAMILY. MEDICAL HISTORY: DEMENTIA AND PARKINSON'S DISEASE. CONCOMITANT MEDICATION: NO INFORMATION WAS PROVIDED. THE OUTCOME OF THE CASE WAS: NO SYMPTOMS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT ADHESIVE CREAM, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLULO DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG. GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R