BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SPIRAL PDS PLUS UNKNOWN

    MDR report key: 14270120 · Received May 3, 2022

    Report

    Report Number
    2210968-2022-03209
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    January 4, 2022
    Report Date
    May 2, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. 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 (STRATAFIX SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (STRATAFIX SUTURE) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. PLEASE VERIFY IF STRATAFIX SUTURE WAS USED IN ALL OF THE 3 WOMEN ASSOCIATED WITH THE EVENT OF MILD ESTHETIC DISCOMFORT WITH A MEAN EURAH-QOL SCORE OF 14, AS IT WAS STATED IN THE ARTICLE THAT A COMPETITOR SUTURE WAS ALSO USED. 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: CITATION: HERNIA. HTTPS://DOI.ORG/10.1007/S10029-021-02547-W. TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, STRENGTH ¿ = 2360 ¿G/M.

    Description of Event or Problem · 0

    TITLE: ROBOTIC TRANSABDOMINAL RETROMUSCULAR RECTUS DIASTASIS (R-TARRD) REPAIR: A NEW APPROACH: THE AIM OF THIS RETROSPECTIVE STUDY OF A PROSPECTIVELY COLLECTED DATA IS TO PRESENT OUR INNOVATIVE ROBOTIC APPROACH FOR THE TREATMENT OF RECTUS DIASTASIS WITH CONCURRENT PRIMARY OR INCISIONAL VENTRAL HERNIAS. A TOTAL OF 45 PATIENTS (13 MALE AND 32 FEMALE) UNDERWENT ROBOTIC TRANSABDOMINAL RETROMUSCULAR RECTUS DIASTASIS (R-TARRD) REPAIRS FOR SYMPTOMATIC RECTUS DIASTASIS WITH CONCOMITANT ASSOCIATED VENTRAL/INCISIONAL UMBILICAL AND/OR EPIGASTRIC HERNIAS BETWEEN JANUARY 2019 AND JANUARY 2020. MEAN AGE WAS 54.8 YEARS (RANGE 31¿68) AND MEAN BMI WAS 26.74 KG/M2 (RANGE 21.1¿31). MEAN ASA WAS 2.2 (RANGE 1¿3). THE PLICATION OF LINEA ALBA WITH REPAIR OF CONCURRENT PRIMARY OR INCISIONAL HERNIAS WAS PERFORMED IN ALL PATIENTS (100%): IN 15 PATIENTS (33.3%), ETHICON STRATAFIX® 0 PDS PLUS ABSORBABLE SUTURE WAS USED, AND IN THE FOLLOWING 30 PATIENTS (66.6%) COMPETITOR DEVICE NON-ABSORBABLE SUTURE WAS USED. IN ALL PATIENTS, A MESH REINFORCEMENT OF LINEA ALBA WAS PERFORMED BY PLACING THE MESH IN A SUBLAY POSITION USING A PROPERLY SHAPED 25 × 15 CM POLYPROPYLENE MESH. FOLLOW-UP WAS SCHEDULED AT 1, 6 MONTHS, AND 1 YEAR AFTER SURGERY. REPORTED COMPLICATIONS INCLUDE HERNIA RECURRENCE, OF WHICH (N=2) WERE SYMPTOMATIC (PAIN AND ABDOMINAL DISCOMFORT WITH A EURAHS-QOL SCORE OF 75) WHICH WERE TREATED WITH RE-INTERVENTION/REOPERATION: ONE IPOM AND ONE OPEN REPAIR. THE OTHER RECURRENT PATIENTS (N=2) REPORTED ONLY ESTHETIC DISCOMFORT WITH A SCORE OF 25. (N=? WOMEN) COMPLAINED A MILD ESTHETIC DISCOMFORT WITH A MEAN EURAH-QOL SCORE OF 14. IN CONCLUSION, ROBOT-ASSISTED TARRD REPAIR IS CONCEIVED AS A NOVEL ALTERNATIVE MINIMALLY INVASIVE PROCEDURE FOR RD WITH CONCURRENT MIDLINE DEFECTS ENSURING A PRIMARY FASCIAL DEFECT CLOSURE AND MESH IMPLANTATION IN A SUBLAY POSITION WITH A WIDE OVERLAP. IT IS IMPORTANT TO BETTER EVALUATE THE SUTURE THAT SHOULD BE USED TO PERFORM THE REPAIR, AND MULTICENTER STUDIES WITH STANDARDIZATION OF PATIENT¿S DEMOGRAPHICS, RD CHARACTERISTICS, AND LONG-TERM FOLLOW-UP OUTCOMES ARE MANDATORY TO ASSESS THE EFFECTIVENESS AND DURABILITY OF R-TARDD REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762769 STRATAFIX SPIRAL PDS PLUS UNKNOWN SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention