BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7931673 · Received October 3, 2018

    Report

    Report Number
    2210968-2018-76292
    Event Type
    Injury
    Date Received
    October 3, 2018
    Report Date
    September 10, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    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. IF FURTHER DETAILS ARE RECEIVED AT THE 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 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 USED IN THIS PROCEDURE? CITATION: EUR J PEDIATR SURG. 2018; 28: 279¿284. DOI: HTTPS://DOI.ORG/10.1055/S-0037-1603088 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: PRIMARY VERSUS STAGED CLOSURE OF EXOMPHALOS MAJOR: CARDIAC ANOMALIES DO NOT AFFECT OUTCOME" AUTHORS: CLARE M. REES, LUCINDA TULLIE, AGOSTINO PIERRO, EDWARD KIELY, JOE I. CURRY, KATE CROSS, ROBERT YATES, SIMON EATON, PAOLO DE COPPI. CITATION: EUR J PEDIATR SURG. 2018; 28: 279¿284. DOI: HTTPS://DOI.ORG/10.1055/S-0037-1603088. THE OBJECTIVE OF THE STUDY IS TO DESCRIBE MANAGEMENT OF EXOMPHALOS MAJOR AND INVESTIGATE THE EFFECT OF CONGENITAL CARDIAC ANOMALIES. THIS IS A SINGLE-CENTER RETROSPECTIVE REVIEW WHICH INCLUDED NEONATES WITH EXOMPHALOS MAJOR (FASCIAL DEFECT = 5CM ± LIVER HERNIATION) BETWEEN 2004 AND 2014. A TOTAL OF 22 PATIENTS (13 MALE AND 9 FEMALE PATIENTS) PRESENTED WITH EXOMPHALOS MAJOR. GESTATIONAL AGE WAS FROM 30 TO 40 WEEKS AND BIRTH WEIGHT FROM 1.4 TO 4.6 KGS. DURING THE PROCEDURE IN THE STAGED CLOSURE WITH SILO GROUP, 15 PATIENTS HAD APPLICATION OF PROLENE MESH (ETHICON) SILO AND SERIAL REDUCTION. OF WHICH, 7 PATIENTS WITH MAJOR CARDIAC ANOMALIES AND 8 PATIENTS WITHOUT CARDIAC ANOMALIES. THE INFANTS HAD 6 PROCEDURES TO TUCK THE SILO BEFORE DEFINITIVE CLOSURE. IN THE STAGED CLOSURE WITH SILO GROUP, REPORTED COMPLICATIONS INCLUDED SAC RUPTURE AND INFECTION (N-1) WHICH REQUIRED REPLACEMENT OF THE TISSUE EXPANDERS, ILEAL PERFORATION (N-1) WHICH REQUIRED LAPAROTOMY WITH OVERSEWING OF THE PERFORATION, SUSPECTED PERFORATION (N-2) WHICH REQUIRED EXPLORATION OF THE BOWEL IN THE SILO, AND VENTRAL HERNIA (N-11). IT WAS REPORTED THAT CLOSING WITH A SILO ALLOWS EARLIER CLOSURE AND AIMS FOR A FASCIAL CLOSURE RATHER THAN A POTENTIALLY MORE CHALLENGING PROCEDURE IN CHILDHOOD TO CLOSE A LARGE VENTRAL HERNIA. THE RESULTS DEMONSTRATE THAT PATIENTS WITH EXOMPHALOS MAJOR CONTINUE TO PRESENT A CHALLENGE TO PEDIATRIC SURGEONS AND MAY HAVE PROLONGED HOSPITAL STAYS IF THE DEFECT CANNOT BE CLOSED PRIMARILY. INFANTS WITH SIGNIFICANT CARDIAC ANOMALIES CAN BE MANAGED WITH PRIMARY OR STAGED CLOSURE, BUT DO NO WORSE THAN INFANTS WITHOUT MAJOR ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770727 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention