BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFXSPI PDS+ UNI VIO 18IN 4-0 SA PS-2 PMP

    MDR report key: 19660974 · Received July 2, 2024

    Report

    Report Number
    2210968-2024-06860
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 22, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031236295
    PMA / PMN Number
    K150670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> PC-(B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. TRADE NAME - IRGACARE® ACTIVE INGREDIENT(S) ¿ TRICLOSAN DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL STRENGTH ¿ = 2360 ¿G/M H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: -* WAS ANY QUALITY DEFICIENCY/NON-CONFORMANCE NOTED WITH THE SUTURE BEFORE USE, DURING USE, DURING POST-OP EXAMINATION OR DURING RE-OPERATION IF PERFORMED? *ANY MEDICAL TREATMENT PROVIDED? IF YES, PLEASE PROVIDE MEDICINE NAME, STRENGTH AND DOSE *DID THE SUTURE BREAK POST-OPERATIVELY? *WAS ANY SURGICAL INTERVENTION PERFORMED SPECIALLY RE-SUTURING? EXPLAIN *WAS DEHISCENCE NOTED? *TISSUE ON WHICH USED? *WHAT IS THE PATIENT?S CURRENT HEALTH STATUS AND CONDITION? 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. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? WAS THE FIXATION LOOP SECURED TO TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE? WAS AT LEAST ONE REVERSE STITCH PERFORMED PRIOR TO CLOSURE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? LOT NUMBER? SURGEON¿S NAME?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION IN (B)(6) 2024 AND SUTURE WAS USED TO PERFORM THE INCISION SKIN SUTURE IN THE WAY OF CONTINUOUS SUTURING. THE INTRAOPERATIVE SUTURE WAS SMOOTH. ABOUT 1 MONTH AFTER THE SURGERY, THE DOCTOR FOUND BY EXAMINATION THAT THE PATIENT HAD WHITE DISCHARGE FROM THE WOUND, THE SUTURE IN THE WOUND WAS DISCHARGED FROM THE SEWING SITE, AND THE WOUND HEALED POORLY. THE DOCTOR REMOVED THE EXPOSED SUTURE AT THE WOUND AND PERFORMED WOUND DEBRIDEMENT AND DRESSING CHANGE. THEN THE PATIENT'S WOUND HEALING WAS IMPROVED, AND NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760133 SFXSPI PDS+ UNI VIO 18IN 4-0 SA PS-2 PMP SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. 10705031236295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention