BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7449794 · Received April 22, 2018

    Report

    Report Number
    2210968-2018-72230
    Event Type
    Injury
    Date Received
    April 22, 2018
    Report Date
    March 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. 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 THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE/ PDS SUTURE) USED IN THIS PROCEDURE? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC PRODUCT CODE AND LOT NUMBER INVOLVED. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE AND TYPE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR ETHICON DEVICES USED? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? CITATION: AESTHETIC SURGERY JOURNAL. 2017; 37(8): NP96 NP97. DOI: 10.1093/ASJ/SJX101 - [(B)(4) - JABBOUR 2017.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: RESPONSE TO ¿THE ASSOCIATION OF PROGRESSIVE TENSION SUTURES AND DRAINS SEEMS TO DECREASE THE DRAINAGE OUTPUT AND SEROMA FORMATION IN ABDOMINOPLASTY¿ AUTHORS: SAMER JABBOUR, MD; RANI MAKHOUL, MD; CYRIL AWAIDA, MD; PHILIPPE LEVAN, MD; TALIAH SCHMITT, MD; AND MARWAN NASR, MD. CITATION: AESTHETIC SURGERY JOURNAL. 2017; 37(8): NP96 NP97. DOI: 10.1093/ASJ/SJX101 IN THE AUTHORS¿ META-ANALYSIS, THEY INCLUDED 2 STUDIES THAT COMPARED THE EFFECT OF PROGRESSIVE TENSION SUTURES (PTS) WITH DRAINS (PTS + D) TO PTS ONLY. IN THE PAST 2 YEARS, THE AUTHORS PERFORMED 70 ABDOMINOPLASTIES USING PTS. TO EVALUATE THE EFFECT OF THE ADDITION OF DRAINS TO PTS, A TOTAL OF 70 PATIENTS WERE DIVIDED INTO 2 GROUPS: 35 PATIENTS HAD PTS + D AT THE END OF THE PROCEDURE (GROUP 1) AND 35 PATIENTS HAD ONLY PTS (GROUP 2). DURING THE PROCEDURE IN ALL GROUPS, THE ABDOMINAL FLAP IS ELEVATED TO THE LEVEL OF THE XIPHOID. IF A DIASTASIS IS PRESENT, ABDOMINAL VERTICAL PLICATION IS DONE FORM XIPHOID TO PUBIS USING PDS 0 RUNNING SUTURES. AFTER RESECTION, THE ABDOMINAL FLAP IS SUTURED TO THE MUSCULAR APONEUROSIS USING BRAIDED VICRYL 1-0 SUTURES. WHILE PROGRESSIVELY ADVANCING THE ABDOMINAL FLAP, 4 EQUIDISTANT SUTURES ARE PLACED ALONG THE MIDLINE. THREE TO 4 ADDITIONAL PTS ARE PLACED LATERALLY ON EACH SIDE OF THE ABDOMINAL FLAP. AFTER EACH SUTURE IS TIED, THE SKIN IS EXAMINED TO PREVENT SURFACE IRREGULARITIES. REPORTED COMPLICATIONS INCLUDED SEROMA (GROUP 1 [N-4]; GROUP 2 [N-1]) WHICH WERE TREATED WITH DRAINAGE AT BEDSIDE OR WITH PUNCTURE AND ASPIRATION, HEMATOMA (GROUP 1 [N-2]; GROUP 2 [N-2]) IN WHICH 2 PATIENTS WERE DRAINED IN THE OPERATING ROOM AND 2 PATIENTS WERE DRAINED AT BEDSIDE, INFECTION (GROUP 1 [N-1]; GROUP 2 [N-1]) WHICH WERE TREATED CONSERVATIVELY BY DRAINAGE AND ANTIBIOTICS, AND WOUND DEHISCENCE (GROUP 1 [N 1]; GROUP 2 [N-1]) WHICH WERE TREATED BY DRESSING CHANGES. IT WAS CONCLUDED THAT THE USE OF PTS IS AN EFFECTIVE MEASURE TO PREVENT SEROMA FORMATION IN ABDOMINOPLASTY WITH NO ADDITIONAL SUCTION DRAINS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292507 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention