BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 8493247 · Received April 8, 2019

    Report

    Report Number
    2210968-2019-80130
    Event Type
    Injury
    Date Received
    April 8, 2019
    Report Date
    March 13, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. CITATION: HINDAWI MINIMALLY INVASIVE SURGERY VOLUME (2018); 6 PAGES. DOI HTTPS://DOI.ORG/10.1155/2018/7123754. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: "ELECTIVE (TRUE DAY CASE) LAPAROSCOPIC INGUINAL HERNIA REPAIR IN A DISTRICT GENERAL HOSPITAL: LESSONS LEARNED FROM 1000 CONSECUTIVE CASES." LAPAROSCOPIC INGUINAL HERNIA REPAIR (LIHR) IS IDEAL FOR DAY CASE SURGERY. IT IS RECOMMENDED THAT AT LEAST 70% SHOULD BE DAY CASES AS A MEASURE OF COST-EFFECTIVENESS. THE AIMS OF THIS REPORT WERE TO ASSESS THE ¿TRUE¿ RATE OF LIHR PERFORMED AS ¿DAY CASES¿, TO IDENTIFY THE IMMEDIATE POSTOPERATIVE COMPLICATIONS EXPERIENCED BY PATIENTS, AND TO IDENTIFY PREDICTORS OF UNEXPECTED PATIENT OVERNIGHT STAY IN A DISTRICT GENERAL HOSPITAL (DGH). THIS STUDY INVOLVES 1000 CONSECUTIVE PATIENTS WHO UNDERWENT LIHR USING THE TRANS-ABDOMINAL PREPERITONEAL (TAPP) APPROACH IN THE INSTITUTION¿S DAY CASE UNIT (DCU) OVER A 7-YEAR PERIOD FROM 2010 TO 2017. NINE HUNDRED AND FIFTEEN PATIENTS WERE SCHEDULED TO UNDERGO LIHR AS ¿DAY CASE ADMISSIONS¿, WHEREAS 85 PATIENTS WERE PREBOOKED FOR OVERNIGHT HOSPITAL STAY CASE BY CASE TAKING INTO CONSIDERATION MULTIPLE FACTORS (PATIENT PREMORBID STATUS/SOCIAL REASONS). THE 915 PATIENTS WHO WERE SCHEDULED TO BE DISCHARGED ON THE DAY OF THEIR PROCEDURE WERE SUBDIVIDED INTO TWO GROUPS: THE TRUE DAY CASE (TDC) GROUP COMPRISED OF 822 PATIENTS (MALE 769 AND FEMALE 53; MEAN AGE 55.5±14.8 YEARS; BMI: 26.4±3.5 KG/M2) WHO ACHIEVED THE TDC TARGET AND THE UNEXPECTED OVERNIGHT STAY (UOS) GROUP COMPRISED OF 93 PATIENTS (MALE 84 AND FEMALE 9; MEAN AGE 63.2±13.83 YEARS; BMI: 25.8±3.5 KG/M2) WHICH REQUIRE UNEXPECTED OVERNIGHT STAY DUE TO A VARIETY OF REASONS. DURING MESH PLACEMENT, A MESH WAS PLACED IN PREPERITONEAL SPACE AND FIXED WITH SECURESTRAP TACKS (ETHICON) PLACED AT LOWER MEDIAL, UPPER MEDIAL, AND UPPER LATERAL CORNERS, AVOIDING LOWER LATERAL CORNER (SO-CALLED ¿TRIANGLE OF SORROW¿). PERITONEUM WAS CLOSED WITH TACKS AVOIDING INFERIOR EPIGASTRIC ARTERY. WOUND CLOSURE WAS PERFORMED USING ¿J¿ PDS (ETHICON) TO DEEP FASCIA AND 3/0 PROLENE (ETHICON) TO SKIN. IN THE UOS GROUP, REPORTED COMPLICATIONS INCLUDED RETENTION OF URINE (N-44) WHICH REQUIRED INSERTION OF URETHRAL CATHETER, POST-OPERATIVE PAIN (N-16), IMMEDIATE POSTOPERATIVE BLEEDING CAUSING HEMATOMA (N-5) WHICH REQUIRE ADMISSION FOR OBSERVATION, AND UNEXPECTED OTHER REASONS (N-5). IN TDC GROUP, REPORTED COMPLICATION INCLUDED RETENTION OF URINE (N-1) WHICH REQUIRED INSERTION OF URETHRAL CATHETER BUT WAS DISCHARGED HOME ON THE SAME DAY. IN CONCLUSION, THE RESULTS DEMONSTRATED THAT LIHR IS A ¿TRUE¿ DAY CASE PROCEDURE IN A DGH. ALTHOUGH SOME FACTORS ASSOCIATED WITH UOS CANNOT BE ALTERED, CAREFUL PATIENT SELECTION AND OPERATING LIST PLANNING ARE OF PARAMOUNT IMPORTANCE IN ORDER TO MINIMISE THE BURDEN ON HEALTHCARE RESOURCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287337 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention