BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 10564362 · Received September 21, 2020

    Report

    Report Number
    2210968-2020-07181
    Event Type
    Injury
    Date Received
    September 21, 2020
    Report Date
    September 11, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ETHICON PRODUCT (MERSILENE SUTURE) INVOLVED? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (MERSILENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER? PATIENT DEMOGRAPHICS? CITATION: ACTA NEUROCHIRURGICA (2020) 162:729¿736; DOI: HTTPS://DOI.ORG/10.1007/S00701-019-04196-6 PLEASE SEE ARTICLE ATTACHED. 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 · 1

    TITLE: SURGICAL NUANCES AND PLACEMENT OF SUBGALEAL DRAINS FOR SUPRATENTORIAL PROCEDURES¿A PROSPECTIVE ANALYSIS OF EFFICACY AND OUTCOME IN 150 CRANIOTOMIES AUTHORS: HUSSAM ALDIN HAMOU; KONSTANTIN KOTLIAR; SONNY KIAN TAN; CHRISTEL WEISS; BLUME CHRISTIAN; HANS CLUSMANN; GERRIT ALEXANDER SCHUBERT; WALID ALBANNA CITATION: ACTA NEUROCHIRURGICA (2020) 162:729¿736; DOI: HTTPS://DOI.ORG/10.1007/S00701-019-04196-6 THIS PROSPECTIVE OBSERVATIONAL STUDY REPORTS THE SURGICAL NUANCES AND PLACEMENT OF SUBGALEAL DRAINS FOR SUPRATENTORIAL PROCEDURES. BETWEEN JANUARY 2014 AND JANUARY 2016, A TOTAL OF 150 CRANIOTOMIES WERE PERFORMED OF WHICH 59 PATIENTS WERE MALE AND MEAN AGE OF ALL CASES WAS 59.1 ± 14.8 YEARS. DURING THE PROCEDURE, STANDARD WOUND CLOSURE WAS PERFORMED BY INTERRUPTED SUTURES (SUBGALEAL LAYER, SUBCUTANEOUS LAYER), FOLLOWED BY CLOSURE OF THE SKIN (SUTURES OR STAPLES). CRANIOTOMY RECONSTRUCTION USING TITANIUM CLAMPS OR POLYESTER SUTURES (MERSILENE; ETHICON) AND INTRAOPERATIVE ANTISEPTIC IRRIGATION WERE USED. REPORTED COMPLICATIONS INCLUDED EARLY PERIORBITAL EDEMA (MODERATE OR SEVERE) (N=?); EARLY SUBGALEAL SWELLING (MODERATE OR SEVERE) (N=?), LATE SUBGALEAL SWELLING (N=?) OF WHICH 2 OF THESE CASES HAD TO UNDERGO OPERATIVE REVISION; WOUND HEALING IMPAIRED (N=?) AND A TOTAL OF 10 HAD TO UNDERGO ANY KIND OF OPERATIVE PROCEDURE (PUNCTURE, SECONDARY STITCHES, OR OPERATIVE REVISION); PAIN, VISUAL ANALOG SCALE (VAS) 5 ¿ 10 (EARLY) (N=?); PAIN, VAS 5 ¿ 10 (LATE) (N=?); INFECTION (N=?). IN CONCLUSION, PERMISSIVE ATTITUDES TOWARDS SURGICAL NUANCES AND PREFERENCES¿INCLUDING THE USE OF SUBGALEAL DRAINS AND DIFFERENCES IN DURAL CLOSURE¿CAN RESULT IN COMPARABLE OUTCOME AFTER SUPRATENTORIAL CRANIOTOMIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025334 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention