BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOT TOPICAL

    MDR report key: 4238951 · Received November 9, 2014

    Report

    Report Number
    1063481-2014-00049
    Event Type
    Malfunction
    Date Received
    November 9, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 16, 2014
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    LMG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE CRYOLIFE SALES REP HAD AN APPOINTMENT TO MEET WITH THE SURGEON CONCERNING PERCLOT. AT THE TIME OF MEETING THE SURGEON HAD AN EMERGENCY EPISTAXIS IN HIS OFFICE. THE PATIENT HAD ON/OFF NOSEBLEED FOR 3 DAYS. THE SURGEON WAS UNABLE TO IDENTIFY THE ORIGIN OF THE BLEEDING OTHER THAN IT WAS FAR POSTERIOR. THE SURGEON UTILIZED A STERILE SAMPLE OF PERCLOT TOPICAL WITH STANDARD TIP. IT APPEARED TO STOP THE BLEEDING. HOWEVER, THE PATIENT DID RETURN LATER THAT DAY, AS HER NOSE BEGAN TO BLEED AGAIN, AND EXPRESSED UPON APPLICATION OF THE PERCLOT EARLIER IT "BURNED LIKE CRAZY DURING APPLICATION". THE SURGEON ENDED UP HAVING TO PACK THE PATIENTS NOSE. ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS COMPLAINT BASED OFF A CONVERSATION WITH THE SURGEON. THE PATIENT DID NOT COMPLAIN OF ANY BURNING OR DISCOMFORT DURING APPLICATION BUT ONLY UPON RETURN WITH RE-BLEED. "PATIENT DID NOT REPORT ANY COUGHING" AFTER APPLICATION. ONLY ONE SIDE OF THE NOSE WAS BLEEDING AND PERCLOT TOPICAL WAS APPLIED TO THAT SIDE. THE SURGEON DID NOT EMPLOY METHODS FOR REMOVING BLOOD PRIOR TO APPLICATION. THE PATIENT WAS BLEEDING PERSISTENTLY AND HE WAS "TRYING TO GET HER OUT OF HERE" AND DID NOT REMOVE EXCESS DRY PARTICLES. THE SURGEON REPORTED THAT THE PATIENT STAYED IN HIS OFFICE FOR OBSERVATION FOR 30 MINUTES FOLLOWING INITIAL APPLICATION OF PERCLOT. THE SURGEON BELIEVES THE PATIENT WAS ON ASPIRIN AND MAY HAVE ALSO BEEN ON PLAVIX. THE SURGEON REPORTED GETTING "GOOD COVERAGE" OF THE POWDER TO THE SURROUNDING ANATOMY AND AFFIRMED THAT FOLLOWING THE APPLICATION, THE PATIENT'S NOSE WAS NOT BLEEDING. HOWEVER, HE EXPRESSED DISAPPOINTMENT THAT THE PRODUCT "DIDN'T WORK" AND HE ENDED UP HAVING TO PACK THE PATIENT AT RETURN. THE SURGEON WOULD LIKE TO TRY TO THE PRODUCT AGAIN ON AN "EASIER CASE". A REVIEW OF THE MANUFACTUING RECORDS FOR THE LOT OF PERCLOT TOPICAL WAS PERFORMED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW AND MET ALL SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST THAT AN ERROR OCCURRED IN PROCESSING OR PRODUCTION. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE AND THE IFU ADEQUATELY COMMUNICATES THE RISKS ASSOCIATED WITH THIS PRODUCT. THE SURGEON'S NAME WAS REMOVED FROM THE DESCRIPTION OF THE EVENT AND ADDITIONAL INFORMATION THAT WAS RECEIVED THROUGH THE COURSE OF THE INVESTIGATION WAS ADDED TO THE DESCRIPTION OF THE EVENT.

    Description of Event or Problem · 1

    THE CRYOLIFE SALES REP HAD AN APPOINTMENT TO MEET WITH DR. (B)(6) ON PERCLOT. AT THE TIME OF MEETING DR. (B)(6) HAD AN EMERGENCY EPISTAXIS IN HIS OFFICE. THE PATIENT HAD ON/OFF NOSEBLEED FOR 3 DAYS. DR. (B)(6) WAS UNABLE TO IDENTIFY THE ORIGIN OF THE BLEEDING OTHER THAN IT WAS FAR POSTERIOR. HE UTILIZED A STERILE SAMPLE OF PERCLOT TOPICAL WITH STANDARD TIP. IT APPEARED TO STOP THE BLEEDING. HOWEVER, THE PATIENT DID RETURN LATER THAT DAY, AS HER NOSE BEGAN TO BLEED AGAIN, AND EXPRESSED UPON APPLICATION OF THE PERCLOT EARLIER IT "BURNED LIKE CRAZY DURING APPLICATION". DR. (B)(6) ENDED UP HAVING TO PACK THE PATIENTS NOSE.

    Description of Event or Problem · 1

    THE CRYOLIFE SALES REP HAD AN APPOINTMENT TO MEET WITH THE SURGEON CONCERNING PERCLOT. AT THE TIME OF MEETING THE SURGEON HAD AN EMERGENCY EPISTAXIS IN HIS OFFICE. THE PATIENT HAD ON/OFF NOSEBLEED FOR 3 DAYS. THE SURGEON WAS UNABLE TO IDENTIFY THE ORIGIN OF THE BLEEDING OTHER THAN IT WAS FAR POSTERIOR. THE SURGEON UTILIZED A STERILE SAMPLE OF PERCLOT TOPICAL WITH STANDARD TIP. IT APPEARED TO STOP THE BLEEDING. HOWEVER, THE PATIENT DID RETURN LATER THAT DAY, AS HER NOSE BEGAN TO BLEED AGAIN, AND EXPRESSED UPON APPLICATION OF THE PERCLOT EARLIER IT "BURNED LIKE CRAZY DURING APPLICATION". THE SURGEON ENDED UP HAVING TO PACK THE PATIENTS NOSE. ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS COMPLAINT BASED OFF A CONVERSATION WITH THE SURGEON. THE PATIENT DID NOT COMPLAIN OF ANY BURNING OR DISCOMFORT DURING APPLICATION BUT ONLY UPON RETURN WITH RE-BLEED. "PATIENT DID NOT REPORT ANY COUGHING" AFTER APPLICATION. ONLY ONE SIDE OF THE NOSE WAS BLEEDING AND PERCLOT TOPICAL WAS APPLIED TO THAT SIDE. THE SURGEON DID NOT EMPLOY METHODS FOR REMOVING BLOOD PRIOR TO APPLICATION. THE PATIENT WAS BLEEDING PERSISTENTLY AND HE WAS "TRYING TO GET HER OUT OF HERE" AND DID NOT REMOVE EXCESS DRY PARTICLES. THE SURGEON REPORTED THAT THE PATIENT STAYED IN HIS OFFICE FOR OBSERVATION FOR 30 MINUTES FOLLOWING INITIAL APPLICATION OF PERCLOT. THE SURGEON BELIEVES THE PATIENT WAS ON ASPIRIN AND MAY HAVE ALSO BEEN ON PLAVIX. THE SURGEON REPORTED GETTING "GOOD COVERAGE" OF THE POWDER TO THE SURROUNDING ANATOMY AND AFFIRMED THAT FOLLOWING THE APPLICATION, THE PATIENT'S NOSE WAS NOT BLEEDING. HOWEVER, HE EXPRESSED DISAPPOINTMENT THAT THE PRODUCT "DIDN'T WORK" AND HE ENDED UP HAVING TO PACK THE PATIENT AT RETURN. THE SURGEON WOULD LIKE TO TRY TO THE PRODUCT AGAIN ON AN "EASIER CASE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721482 PERCLOT TOPICAL ABSORBABLE HEMOSTATIC AGENT LMG CRYOLIFE, INC. STA0003-T MS14C11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other