BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7684040 · Received July 12, 2018

    Report

    Report Number
    2210968-2018-74325
    Event Type
    Injury
    Date Received
    July 12, 2018
    Report Date
    June 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 PRODUCT (SILK SUTURE) USED IN THIS PROCEDURE? CITATION: AESTH PLAST SURG. 2016; 40: 707¿715. DOI: 10.1007/S00266-016-0675-0. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: APPLICATION OF NIPPLE RETRACTOR FOR CORRECTION OF NIPPLE INVERSION: A 10-YEAR EXPERIENCE. AUTHOR: LIU YUKUN, GUO KE, SUN JIAMING. CITATION: AESTH PLAST SURG. 2016; 40: 707¿715. DOI: 10.1007/S00266-016-0675-0. NIPPLE INVERSION IS A RELATIVELY COMMON PROBLEM IN ADOLESCENT AND ADULT WOMEN; HOWEVER, MOST PRESENT SURGICAL TREATMENTS ARE PRONE TO INJURE THE LACTIFEROUS DUCTS AND IMPAIR THE BREAST FEEDING FUNCTION. TO SIMPLIFY THE OPERATION PROCEDURES AND DIMINISH THE POSSIBILITY OF LACTIFEROUS DUCT INJURY, THE AUTHORS DEVELOPED A NIPPLE RETRACTOR, WHICH WAS MADE FROM A SINGLE-USE SYRINGE, TO CORRECT NIPPLE INVERSION. A TOTAL OF 257 NIPPLES FROM 136 PATIENTS RECEIVED THE SURGICAL PROCEDURE FROM JAN 2003 TO DEC 2012. PATIENT AGES RANGED FROM 17¿34 YEARS WITH A MEAN AGE OF 25.8 YEARS. OF WHICH, 15 PATIENTS HAD UNILATERAL INVERSIONS, AND THE OTHER 121 PATIENTS WERE BILATERAL. DURING THE PROCEDURE, AN 18-GA INJECTING NEEDLE WITH A DIAMETER OF 1.2 MM WAS USED TO PREPARE THE HOLES ON THE BASE, AND CROSS SUTURING ON THE BASE OF THE NIPPLE WAS PERFORMED WITH SINGLE MERSILK 1¿0 OR DOUBLE MERSILK 2¿0 MERSILK NON-ABSORBABLE SUTURES. THE HORIZONTAL AND VERTICAL SUTURES USING SINGLE MERSILK 1¿0 OR DOUBLE MERSILK 2¿0 NON-ABSORBABLE SUTURE WERE PERFORMED TO CROSS THE BASE OF THE NIPPLE, UNTIL THE NIPPLE COULD BE DRAWN OUT BY STRETCHING THE SUTURES UPWARD. REPORTED COMPLICATIONS INCLUDED NIPPLE INVERSION RECURRENCE (N-24), SUTURE FISTULA (19 NIPPLES) IN WHICH 15 CASES WERE HEALED AFTER 1 MONTH AND 4 CASES WERE SURGICALLY REMOVED 3 MONTHS LATER, BREAKING OF SUTURES (8 NIPPLES) IN WHICH THE RETRACTORS WERE REMOVED AND THE INVOLVED NIPPLES WERE WELL CORRECTED, AND CHRONIC PAIN (10 NIPPLES) WHICH DISAPPEARED AFTER REMOVAL OF THE RETRACTORS. IT WAS CONCLUDED THAT THE RETRACTOR TECHNIQUE IS A FEASIBLE METHOD FOR CORRECTION OF NIPPLE INVERSIONS DUE TO ITS SIMPLICITY AND EFFECTIVENESS. THE PROCEDURE IS SIMPLE, AND ITS SAFETY AND EFFICACY ARE RELIABLE. THE MOST SIGNIFICANT ADVANTAGE IS THAT LACTIFEROUS DUCT INJURY IS AVOIDED AND THE BREASTFEEDING FUNCTION IS PRESERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526206 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention