BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7375595 · Received March 27, 2018

    Report

    Report Number
    2210968-2018-71693
    Event Type
    Injury
    Date Received
    March 27, 2018
    Report Date
    March 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: ORBIT, 29(1), 7¿10, 2010 COPYRIGHT © 2010 INFORMA HEALTHCARE USA, INC. ISSN: (B)(4) PRINT/ 1744-5108 ONLINE; DOI: 10.3109/01676830903207810 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: THE ¿MINI TARSAL STRIP¿ LATERAL CANTHOPEXY FOR LOWER EYELID LASER-ASSISTED ¿ BLEPHAROPLASTY¿INDICATIONS, TECHNIQUE AND COMPLICATIONS IN 614 CASES AUTHORS: JAMES H. OESTREICHER MD, FRCSC, AND KIA TARASSOLY MD CITATION: ORBIT, 29(1), 7¿10, 2010 COPYRIGHT © 2010 INFORMA HEALTHCARE USA, INC. ISSN: (B)(4) PRINT/ 1744-5108 ONLINE; DOI: 10.3109/01676830903207810. THIS PAPER REPORTED THE RESULT OF MINI TARSAL STRIPS PROCEDURE, IN WHICH THE MAJORITY WERE ACCOMPANIED WITH TRANS-CONJUNCTIVAL LOWER LID BLEPHAROPLASTIES. BETWEEN JANUARY 2006 AND NOVEMBER 2008, 614 MINI TARSAL STRIP PROCEDURES WERE PERFORMED ON 307 MALE AND FEMALE PATIENTS, AGES 21 TO 88 YEARS. LOWER LID BLEPHAROPLASTIES WERE PERFORMED USING THE CO2 LASER THROUGH A TRANS-CONJUNCTIVAL INCISION UNDER LOCAL ANESTHESIA WITH INTRAVENOUS (IV) SEDATION AND MEDIAL, CENTRAL AND LATERAL ORBITAL FAT PADS WERE REMOVED APPROPRIATELY. SKIN RESURFACING WAS DONE USING A CONVENTIONAL TWO-PASS TECHNIQUE IN SUPER PULSE MODE WHERE APPROPRIATE. CYST FORMATION AT THE SITE OF THE INCISION IN 11 EYES BETWEEN 1 WEEK AND 3 MONTHS POSTOPERATIVELY. TWO OF THEM REQUIRED SURGICAL EXCISION AND WERE CONFIRMED AS EPIDERMAL INCLUSION CYSTS BY THE PATHOLOGY REPORT; THE REST WERE OBSERVED AND RESOLVED OVER TIME. LOCALIZED REDNESS AND SCARRING (N=7) WERE ALSO REPORTED WHICH WAS TRANSIENT AND RESOLVED OVER TIME AIDED BY HAVING THE PATIENT MASSAGE THE EYELIDS. VICRYL SUTURE PROTRUSION (N=7) WERE ALSO REPORTED WHERE VICRYL SUTURE ENDS WERE FOUND EXPOSED AND WERE TRIMMED OR REMOVED. IN CONCLUSION, THE AUTHORS WROTE THAT THE SMALL INCISION MINITARSAL STRIP PROCEDURE WAS RECOMMENDED AS THE PREFERRED LID TIGHTENING PROCEDURE IN TRANSCONJUNCTIVAL LOWER LID BLEPHAROPLASTY. IT WAS EASY TO PERFORM AND HAS A MINIMAL COMPLICATION RATE AND OFFERED LID TIGHTENING WITHOUT EXPOSING THE PATIENT TO THE COMPLICATIONS OF STANDARD LOWER LID TIGHTENING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216559 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention