BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7639041 · Received June 26, 2018

    Report

    Report Number
    2210968-2018-73842
    Event Type
    Injury
    Date Received
    June 26, 2018
    Report Date
    June 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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: OPHTHAL PLAST RECONSTR SURG 2012; 28:213¿218 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: THE LIFT AND FILL LOWER BLEPHAROPLASTY AUTHORS: GUY G. MASSRY, MD AND MORRIS E. HARTSTEIN, MD CITATION: OPHTHAL PLAST RECONSTR SURG 2012; 28:213¿218; DOI: 10.1097/IOP.0B013E318248E6A1 THE AIM OF THIS RETROSPECTIVE STUDY WAS TO STUDY A SERIES OF PATIENTS WHO UNDERWENT COMBINED LOWER CONJUNCTIVAL BLEPHAROPLASTY WITH FAT REPOSITIONING AND ORBICULARIS MUSCLE SUSPENSION, ¿THE LIFT AND FILL LOWER BLEPHAROPLASTY¿, AS A MEANS OF IMPROVING LOWER EYELID, AND EYELID/CHEEK INTERFACE AESTHETICS AFTER SURGERY. BETWEEN THE PERIOD OF 2007 AND 2010, INFORMED CONSENT WAS OBTAINED FOR EACH PROCEDURE, AND THE REVIEW ADHERED TO THE STANDARDS OF THE DECLARATION OF HELSINKI AND WAS HIPAA COMPLIANT. DURING THE PROCEDURE, A 4-0 PROLENE SUTURE ON A PS-2 NEEDLE IS PASSED THROUGH SKIN INTO THE WOUND BELOW THE DEMARCATED TEAR TROUGH. THE NEEDLE IS RETRIEVED AND PASSED IN A HORIZONTAL MATTRESS FASHION THROUGH THE NASAL FAT FLAP AND THEN BACK IN THE WOUND AND EXITING THE SKIN. ORBICULARIS SUSPENSION IS PERFORMED IN 2 WAYS. IF A CANTHOPLASTY IS NEEDED IT IS PERFORMED AS PREVIOUSLY DESCRIBED 10,12 PRIOR TO MUSCLE PLICATION. THE TERMINAL PRESEPTAL ORBICULARIS MUSCLE IS ENGAGED WITH A 5-0 VICRYL SUTURE AND ELEVATED AND SECURED TO THE LATERAL ORBITAL RIM PERIOSTEUM. MINOR COMPLICATIONS INCLUDED 1 SUTURE ABSCESS AND 1 MILD GRANULOMA AT THE LATERAL CANTHUS. THE GRANULOMA RESOLVED AFTER 1 INJECTION OF THE 5FU/K5 MIXTURE PREVIOUSLY DESCRIBED. THE ABSCESS REQUIRED MINOR IN-OFFICE INCISION/DRAINAGE. THERE WAS A SMALL CANTHAL WEB NOTED BY THE SURGEON ONLY IN 1 PATIENT. NO REVISION WAS PERFORMED. MOST PATIENTS EXPERIENCED TRANSIENT GRANULOMAS OF REPOSITIONED FAT WHICH ALL RESOLVED WITHIN A MONTH. FIVE OF THESE PATIENTS REQUIRED 1 OR 2 OF THE SAME 5FU/K5 INJECTIONS. FINALLY, 1 PATIENT UNDERWENT ADDITIONAL SKIN EXCISION IN THE OFFICE 6 MONTHS AFTER SURGERY. ALL PATIENTS HAD SIGNIFICANT IMPROVEMENT IN LOWER EYELID APPEARANCE, CONTOUR, AND IN THE TRANSITION OF THE EYELID TO THE CHEEK AS OBSERVED BY BOTH PHYSICIAN AND PATIENT. IN CONCLUSION, THE COMBINATION OF TRANSCONJUNCTIVAL LOWER BLEPHAROPLASTY WITH FAT REPOSITIONING, AND ORBICULARIS MUSCLE SUSPENSION, ¿THE LIFT AND FILL LOWER BLEPHAROPLASTY,¿ PROVIDES A RELIABLE AND REPRODUCIBLE AESTHETIC REJUVENATION OF THE LOWER EYELID AND ITS TRANSITION TO THE CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481066 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention