BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 15709651 · Received November 1, 2022

    Report

    Report Number
    2210968-2022-07607
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    August 22, 2020
    Report Date
    September 15, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT INITIALLY SUBMITTED ON 9/15/2022. A RESPONSE WAS RECEIVED FROM THE FDA TO RESUBMIT THE REPORT BECAUSE ACK 3 WAS NOT GENERATED AND THE REPORT WAS STUCK IN TRANSMISSION. THE FDA GATEWAY PREVENTED TRANSMISSION OF THIS REPORT. PLEASE REFERENCE FDA TICKET (B)(4) FOR ADDITIONAL DETAILS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: CHINA MODERN MEDICINE, AUGUST 2020, VOL. 27, NO. 22.

    Description of Event or Problem · 0

    TITLE: APPLICATION OF RED LIGHT IRRADIATION IN OPERATIVE INCISION OF CALCANEAL FRACTURE. THE OBJECTIVE OF THE STUDY IS TO INVESTIGATE THE EFFECT OF RED-LIGHT IRRADIATION ON SURGICAL INCISION OF CALCANEAL FRACTURE. FROM JANUARY 2017 TO JANUARY 2019, 90 PATIENTS WITH CALCANEAL FRACTURE WERE INCLUDED IN THE STUDY. THE PATIENTS WERE RANDOMLY DIVIDED INTO OBSERVATION GROUP AND CONTROL GROUP WITH 45 PATIENTS IN EACH GROUP. IN THE OBSERVATION GROUP, THERE WERE 27 MALES AND 18 FEMALES WITH A MEAN AGE OF 32.083 +/- 8.220 YEARS (RANGE 20-52 YEARS). IN THE CONTROL GROUP, THERE WERE 25 MALES AND 20 FEMALES WITH A MEAN AGE OF 33.250 +/- 7.878 YEARS (RANGE 21-50 YEARS). BOTH GROUPS WERE TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION. AFTER SATISFACTORY REDUCTION, UNKNOWN MANUFACTURER LATERAL CALCANEAL PLATE AND SCREW FIXATION WERE APPLIED, AND THE SUBCUTANEOUS TISSUE WAS ROUTINELY SUTURED AFTER SURGERY. THE NO.1 SILK SUTURE (ETHICON) WAS USED TO SUTURE THE INCISION TO AVOID TOO TIGHT KNOTTING AND SKIN INVERSION. THE INCISIONS IN THE OBSERVATION GROUP WERE PROVIDED AFTER OPERATION WITH RED LIGHT IRRADIATION BESIDES CONVENTIONAL DRESSING CHANGES, WHILE IN THE CONTROL GROUP, ROUTINE DRESSING CHANGE ALONE. BOTH GROUPS OF PATIENTS WERE FOLLOWED UP FOR 3 MONTHS AFTER SURGERY. THE REPORTED COMPLICATIONS INCLUDED INFLAMMATORY REACTION (N=7), SKIN EDGE NECROSIS (N=10), INCISION DEHISCENCE (N=4), AND WOUND INFECTION (N=3). IN CONCLUSION, RED LIGHT IRRADIATION CAN SHORTEN THE EXUDATION AND HEALING TIME OF INCISION, REDUCE THE DEGREE OF PAIN, REDUCE THE INCIDENCE OF INFLAMMATORY REACTION AND SKIN EDGE NECROSIS IN PATIENTS UNDERGOING CALCANEAL FRACTURE SURGERY, WHICH HAS CLINICAL APPLICATION VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058468 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention