BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19122611 · Received April 16, 2024

    Report

    Report Number
    2210968-2024-04401
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    October 21, 2022
    Report Date
    April 16, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J. CLIN. MED. 2022,11,6206. HTTPS://DOI.ORG/10.3390/JCM11206206

    Description of Event or Problem · 0

    TITLE: A RETROSPECTIVE TAIWANESE-POPULATION-BASED CLINICAL STUDY ON DETERMINING THE EFFICACY AND SAFETY OF DISPOSABLE CIRCUMCISION ANASTOMAT THE OBJECTIVE OF THIS STUDY IS TO INVESTIGATE THE SURGICAL OUTCOMES OF RECENTLY THE DISCOVERED DISPOSABLE CIRCUMCISION ANASTOMAT TYPE A (DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LTD., CHINA), A DISPOSABLE CIRCUMCISION SUTURE DEVICE (DCSD), IN TERMS OF THE OPERATION TIME, SURGICAL COMPLEXITY, SAFETY, SATISFACTION, AND AESTHETIC OUTCOMES AND MOST IMPORTANTLY THE PROGNOSTIC FACTORS FOR POSTOPERATIVE INFECTION. BETWEEN (B)(6) 2020 TO (B)(6) 2021, A TOTAL OF 490 PATIENTS WITH REDUNDANT PREPUCE OR RECURRENT BALANOPOSTHITIS RECEIVED CIRCUMCISION BY THE DISPOSABLE CIRCUMCISION SUTURE DEVICE (DCSD). HOWEVER, WE RETROSPECTIVELY ENROLLED 394 PATIENTS BASED ON THE EXCLUSION CRITERIA SUCH AS LOSS OF POSTOPERATIVE FOLLOW-UP, ANY MISSING LABORATORY DATA, OR MEDICAL RECORDS. THE MEAN OPERATION TIME WAS 31.4 9.96 MIN AND THE AVERAGE POSTOPERATIVE BLEEDING, AND THE WOUND INFECTION RATE WAS 2.54% AND 9.39% OF THE TOTAL POPULATION, RESPECTIVELY. BESIDES INFECTION, WE ALSO OBSERVED A CASE OF HEMATOMA WITHIN THE 10 BLEEDING CASES. A FEW CASES OF INSTRUMENT MALFUNCTION WERE ALSO EVIDENCED. IN TOTAL, 37 OUT OF 394 PATIENTS WERE OBSERVED WITH WOUND INFECTION. THE GLANS PEDESTAL WAS INSERTED INTO THE PREPUCE AND KEPT IN PROPER TENSION BY FORCEPS. WE THEN CONSTRAINED THE FORESKIN WITH 4-0 SILK ACHIEVING A DRAWSTRINGPOCKET-LIKE MODEL. BEFORE WE TIED UP THE SUTURE, AND THE SHAFT WAS TILTED TO AN ANGLE OF 30¿45 DEGREES FROM THE HORIZONTAL LEVEL TO PRESERVE THE FRENULUM. AFTER THE PROCEDURE, WE COMPRESSED THE WOUND FOR FIVE MINUTES, AND THE RUBBER RING WAS CUT EVERY 3¿5 NAILS TO PREVENT OVER-COMPRESSION. IF ACTIVE BLEEDING WAS NOTED, A STATE SUTURE WITH A 4-0 MONOCRYL STATE SUTURE WAS APPLIED. THEN, THE CIRCULAR WOUND DRESSING WAS COMPLETED WITH A SELF-ADHESIVE FLEXIBLE BANDAGE. REPORTED COMPLICATIONS INCLUDED BLEEDING (N=10), INFECTION (N=37), HEMATOMA (N=1), POSTOPERATIVE PAIN (N=?), INSTRUMENT MALFUNCTION (N=8) AND REOPERATION (N=5). IN CONCLUSION, DSCD COULD BE AN EFFECTIVE AND SAFE ALTERNATIVE TO PERFORMING CIRCUMCISION. HOWEVER, IN THE POPULATION WITH ADVANCED AGING, PHIMOSIS, ELEVATED BMI, AND DM (HBA1C > 9%), USERS SHOULD BE HIGHLY CAUTIOUS DUE TO THE INCREASED RISK OF INFECTION, DEHISCENCE, AND HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024431 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention