BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 9181486 · Received October 11, 2019

    Report

    Report Number
    2210968-2019-88515
    Event Type
    Injury
    Date Received
    October 11, 2019
    Report Date
    September 17, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. 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. 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 INVOLVED (PDS SUTURE, VICRYL SUTURE) 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 (PDS SUTURE, VICRYL SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. CITATION: WORLD J SURG (2018) 42:1687¿1694; HTTPS://DOI.ORG/10.1007/S00268-017-4363-2; PUBLISHED ONLINE: 20 NOVEMBER 2017 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE "TITLE : PROPHYLACTIC INTRAPERITONEAL ONLAY MESH REINFORCEMENT REDUCES THE RISK OF INCISIONAL HERNIA, TWO-YEAR RESULTS OF A RANDOMIZED CLINICAL TRIAL". AUTHORS : PHILIPPE BROSI, PHILIPPE M. GLAUSER, BENJAMIN SPEICH, SAMUEL A. KASER, CHRISTOPH A. MAURER CITATION: WORLD J SURG (2018) 42:1687¿1694; HTTPS://DOI.ORG/10.1007/S00268-017-4363-2; PUBLISHED ONLINE: 20 NOVEMBER 2017. THIS PROSPECTIVE, MONOCENTRIC, PARALLEL-GROUP, RANDOMIZED, CONTROLLED, OPEN-LABELLED TRIAL EXAMINES THE FEASIBILITY, SAFETY AND INCISIONAL HERNIA RATE OF THE USE OF A PROPHYLACTIC INTRAPERITONEAL ONLAY MESH STRIPE (IPOM) TO PREVENT INCISIONAL HERNIA FOLLOWING MIDLINE LAPAROTOMY. BETWEEN JUNE 2008 AND MAY 2013, A TOTAL OF 267 PATIENTS WERE RANDOMLY ALLOCATED TO TWO DIFFERENT GROUPS. 131 PATIENTS (MALE N=60, FEMALE N=71, MEAN AGE 64.1 YEARS) TO GROUP A (INTERVENTION WITH IPOM) AND 136 PATIENTS (MALE N=56, FEMALE 80, MEAN AGE 65.1 YEARS) TO GROUP B (CONTROL, WITHOUT IPOM). THE MATERIAL USED FOR ABDOMINAL WALL CLOSURE IN BOTH GROUPS WERE LATE ABSORBABLE MONOFILAMENT POLYDIOXANONE LOOP SUTURES (PDS II SIZE 1; ETHICON BY JOHNSON & JOHNSON, NEW BRUNSWICK, NJ, USA) WITH A NEW SUTURE EVERY 10 CM. THE ABDOMINAL WALL CLOSURE WAS FINISHED WITH A SUBCUTANEOUS CONTINUOUS SUTURE USING ABSORBABLE MATERIAL (VICRYL, SIZE 3-0; ETHICON); THE SKIN WAS CLOSED USING A SKIN STAPLER (PROXIMATE; ETHICON). COMPLICATIONS INCLUDED BURST ABDOMEN (N=5), BOWEL PERFORATION (N=1), RETROPERITONEAL INFECTION (N=1), POSTOPERATIVE PAIN (N=?), HEMATOMA (N=6), SEROMA (N=4), SUBCUTANEOUS INFECTION (N=5), INTRAABDOMINAL ABSCESS (N=3). IN CONCLUSION, THIS FIRST RANDOMIZED CLINICAL TRIAL INDICATES THAT THE PLACEMENT OF A NON-ABSORBABLE IPOM-STRIPE WITH PROPHYLACTIC INTENTION MAY SIGNIFICANTLY REDUCE THE RISK FOR A MIDLINE INCISIONAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972426 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention