BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 21792894 · Received April 7, 2025

    Report

    Report Number
    2210968-2025-03672
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    August 12, 2024
    Report Date
    April 7, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 3. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 4. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 5. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? CITATION: HEAD & NECK. 2024; 46:2650¿2656. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PATEL VM, ALSHAMMARI SM, JANG DW, ZOMORODI AR, ABI HACHEM R. THE LATERAL BASED NASOPHARYNGEAL FLAP: A NOVEL VASCULARIZED FLAP FOR SKULL BASE RECONSTRUCTION. HEAD NECK. 2024 OCT;46(10):2650-2656. DOI: 10.1002/HED.27911. EPUB 2024 AUG 12. PMID: 39132775. THIS RETROSPECTIVE STUDY DESCRIBES A NOVEL FLAP AND SURGICAL TECHNIQUE TO RECONSTRUCT DEFECTS IN THE NASOPHARYNX USING A LATERAL BASED NASOPHARYNGEAL FLAP. TWO (N=2) PATIENTS WHO UNDERWENT RECONSTRUCTION USING THE LATERAL BASED NASOPHARYNGEAL FLAP FOR CSF LEAKS IN THE NASOPHARYNGEAL AREA. BOTH PATIENTS INCLUDED IN THE STUDY HAD AT LEAST ONE PRIOR ENDOSCOPIC ENDONASAL SKULL BASE RECONSTRUCTION THAT FAILED. REPORTED COMPLICATIONS ARE SURGICEL (ETH) CASE 1: 14-YEAR-OLD MALE (N=1). PERSISTENT HEADACHES TREATMENT NOT REPORTED. HIGH PRESSURE HYDROCEPHALUS TREATMENT: VP SHUNT. IN CONCLUSION, THE LATERAL BASED NASOPHARYNGEAL FLAP IS A NOVEL FLAP THAT IS VASCULARIZED BY BRANCHES FROM THE ASCENDING PHARYNGEAL ARTERY AND IS COMPOSED OF THE NASOPHARYNGEAL MUCOSA AND THE SUPERIOR PHARYNGEAL CONSTRICTOR MUSCLE. IT IS BEST USED TO RECONSTRUCT DEFECTS IN THE NASOPHARYNX INCLUDING THE LOWER CLIVUS AND THE EUSTACHIAN TUBE WITH A HIGH RATE OF SUCCESS AND LOW MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604671 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Required Intervention