BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 18215068 · Received November 28, 2023

    Report

    Report Number
    2210968-2023-09231
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    February 1, 2023
    Report Date
    November 28, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-09230 AND 2210968-2023-09231. CITATION: DIAGNOSTICS 2023, 13, 529. HTTPS://DOI.ORG/10.3390/DIAGNOSTICS13030529.

    Description of Event or Problem · 0

    TITLE: COMPARING OUTCOMES OF SINGLE-INCISION LAPAROSCOPIC HERNIORRHAPHY IN NEWBORNS AND INFANTS THE AIM OF THIS STUDY WAS TO ANALYZE THE OUTCOMES OF NEWBORNS AND INFANTS WHO UNDERWENT SINGLE-INCISION LAPAROSCOPIC HERNIORRHAPHY. BETWEEN MARCH 2016 TO AUGUST 2020, 197 PATIENTS (157 MALES AND 40 FEMALES) YOUNGER THAN 12 MONTHS OLD WHO RECEIVED SINGLE-INCISION LAPAROSCOPIC HERNIORRHAPHY WERE INCLUDED IN THE STUDY. AT THE TIME OF SURGERY, GROUP 1 NEWBORNS, WHOSE CORRECTED AGE WAS 2 MONTHS AND BELOW, WERE COMPARED TO THE GROUP 2 INFANTS, WHOSE AGE WAS ABOVE 2 MONTHS. GROUP 1 CONSISTED OF 114 NEWBORNS AND GROUP 2 CONSISTED OF 83 INFANTS. THE MEAN AGE AND BODY WEIGHT IN GROUP 1 WERE 1.2 MONTHS AND 3.8 KG, RESPECTIVELY, WHEREAS IN GROUP 2, THEY WERE 3.2 MONTHS AND 6.7 KG, RESPECTIVELY. ALL PATIENTS UNDERWENT LAPAROSCOPIC HERNIA REPAIR. A 3¿0 NON-ABSORBABLE MULTIFILAMENTOUS SUTURE 17 MM 1/2 ROUND-BODIED NEEDLE MERSILK (ETHICON) WAS USED TO CLOSE THE RING DEFECT IN A PURSE-STRING FASHION. THE PORT SITE WAS CLOSED WITH A 2-0 VICRYL (ETHICON) SIMPLE SUTURE OF THE FASCIA AND 4-0 VICRYL (ETHICON) SUBCUTANEOUSLY FOR THE SKIN. MOST INFANTS OVER 50 GESTATIONAL WEEKS OF AGE WERE OPERATED ON IN THE DAY-SURGERY CENTER AND WERE DISCHARGED 1 H AFTER SURGERY. PATIENTS UNDER 50 GESTATIONAL WEEKS OF AGE WERE ALL ADMITTED AND OBSERVED AFTER SURGERY. POSTOPERATIVELY, THE PATIENTS RETURNED TO THE NEONATAL CARE NURSERY OR INFANT CARE NURSERY FOR APNEA MONITORING. SIMPLE ANALGESIA (PARACETAMOL) WAS USED FOR PAIN RELIEF. PATIENTS WERE FOLLOWED UP AT 1 WEEK, 1 AND 12 MONTHS POSTOPERATIVELY TO EVALUATE OUTCOMES. REPORTED COMPLICATIONS INCLUDED OMPHALITIS (N=7) AND SURGICAL SITE INFECTION (N=2). IN CONCLUSION, SINGLE-INCISION LAPAROSCOPIC HERNIORRHAPHY IS A SAFE AND EFFECTIVE OPERATION FOR INGUINAL HERNIA REPAIR IN INFANTS, EVEN THOSE WITH PREMATURITY, LOWER BODY WEIGHT AT THE TIME OF SURGERY, OR CARDIAC AND/OR PULMONARY COMORBIDITIES. COMPARABLE RESULTS REVEALED NO SIGNIFICANT DIFFERENCES IN PERIOPERATIVE COMPLICATIONS DESPITE YOUNGER AGES AND LOWER BODY WEIGHTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599976 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other