BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 8476404 · Received April 2, 2019

    Report

    Report Number
    2210968-2019-79930
    Event Type
    Injury
    Date Received
    April 2, 2019
    Report Date
    March 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    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. 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. 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 (VICRYL PLUS SUTURE) 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 (VICRYL PLUS SUTURE) USED IN THIS PROCEDURE? CITATION: AESTH PLAST SURG (2018) 42:1231¿1243. DOI: HTTPS://DOI.ORG/10.1007/S00266-018-1128-8. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: AXILLARY ACCESSORY BREAST: OPTIMAL TIME FOR OPERATION". AUTHOR(S): SUNG RYUL LEE, SEUNG GEUN LEE, GEON YOUNG BYUN, MYOUNG JIN KIM, BUM HWAN KOO. CITATION: AESTH PLAST SURG (2018) 42:1231¿1243. DOI: HTTPS://DOI.ORG/10.1007/S00266-018-1128-8. AN ACCESSORY BREAST OCCURS IN 2¿6% OF WOMEN AND IS USUALLY FOUND IN THE AXILLA. PATIENTS WITH AN ACCESSORY BREAST MAY HAVE NO SYMPTOMS, BUT SOME PATIENTS REQUIRE TREATMENT FOR PAIN OR COSMESIS. THIS PURPOSE OF THIS STUDY WAS TO DETERMINE THE OPTIMAL TIME FOR AXILLARY ACCESSORY BREAST (AAB) EXCISION AND ELUCIDATE THE VARIATIONS IN CLINICAL PRESENTATIONS AND SURGICAL OUTCOMES CAUSED BY PREGNANCY. THIS STUDY INVOLVED 540 WOMEN WHOSE SYMPTOMS BEGAN FROM PUBERTY AND UNDERWENT AAB EXCISION. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: GROUP 1 COMPRISED OF 416 PATIENTS (AGE RANGE: 13-46 YEARS OLD; BMI 154.-40.0 KG/M2) WHO UNDERWENT OPERATIONS BEFORE PREGNANCY AND GROUP 2 COMPRISED OF 124 PATIENTS (AGE RANGE: 23-65 YEARS OLD; BMI 17.6-32.0 KG/M2) WHO UNDERWENT OPERATIONS AFTER CHILDBIRTH. DURING THE PROCEDURE, A 1-CM-LONG INCISION WAS MADE TO REMOVE THE ACCESSORY BREAST TISSUE WITH SIMULTANEOUS LIPOSUCTION. THE SUBCUTANEOUS TISSUE WAS APPROXIMATED WITH VICRYL PLUS 4-0 ABSORBABLE SUTURES (ETHICON). IN GROUP 1, REPORTED EARLY COMPLICATIONS INCLUDED SEROMA (N-20), HEMATOMA (N-5), INFECTION (N-2), AND SKIN AND SUBCUTANEOUS ADHESIONS. LATE COMPLICATIONS INCLUDED NUMBNESS OF AXILLA (N-2), HYPERTROPHIC SCAR (N-4), AND HYPERPIGMENTATION (N-6). IN GROUP 2, REPORTED EARLY COMPLICATIONS INCLUDED SEROMA (N-8), HEMATOMA (N-3), INFECTION (N-2), AND SKIN AND SUBCUTANEOUS ADHESIONS. LATE COMPLICATIONS INCLUDED HYPERTROPHIC SCAR (N-5), AND HYPERPIGMENTATION (N-5). IN CONCLUSION, THE OPTIMAL TIMING FOR OPERATION FOR AAB APPEARS TO BE BEFORE THE ONSET OF PREGNANCY BECAUSE OF LOWER REOPERATION RATES AND GREATER PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266589 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention