BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 9885395 · Received March 26, 2020

    Report

    Report Number
    2210968-2020-02386
    Event Type
    Injury
    Date Received
    March 26, 2020
    Date of Event
    January 6, 2020
    Report Date
    March 13, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 4/15/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS MEDICATION PRESCRIBED FOR THE SUPERFICIAL SITE INFECTION? IF YES, PLEASE DESCRIBE. ANTIBIOTICS WERE PRESCRIBED. CANNOT REMEMBER THE NAME OF THE MEDICINE. DATE AND NAME OF INDEX SURGICAL PROCEDURE - CANNOT ASSOCIATE A PROCEDURE NAME TO A SPECIFIC COMPLAINT. FOR THESE 4 COMPLAINTS, IT CAN BE A PTOSIS CURE, A BREAST IMPLANT OR A THIGH LIFTING. ON WHAT TISSUE WAS THE SUTURE USED? THE DEVICE WAS USED ON SKIN AND SUBCUTANEOUS TISSUE. WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? THE TISSUE WAS NORMAL. WHAT WERE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? THE HEALING WAS NORMAL DURING THE 3 FIRST WEEKS, THE INFECTION OCCURRED AFTER THEN. WERE CULTURES PERFORMED? IF YES, RESULTS? DID NOT KNOW IF CULTURE WAS PERFORMED. WHAT IS THE PATIENT¿S CURRENT STATUS? THE PATIENTS GO WELL. 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. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE THERE ANY CHANGES TO CLEANSING REGIMENS PREOPERATIVELY? WHAT WERE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA-OP? DID THE PATIENT RECEIVE ORAL OR TOPICAL ANTIBIOTICS? WERE CULTURES PERFORMED? RESULTS? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS. PLEASE CLARIFY LOT NUMBER MMBDRJO AS IT IS NOT A VALID LOT. IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S STATUS? NOTE: EVENTS REPORTED VIA MW 2210968-2020-02385, 2210968-2020-02387, 2210968-2020-02389.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROCEDURE WAS REPORTED TO BE PTOSIS CURE, BREAST IMPLANT OR THIGH LIFT AND DEVICE WAS USED ON SKIN AND SUBCUTANEOUS TISSUES. THE PATIENT HEALING WAS NORMAL DURING THE FIRST THREE WEEKS POST-OP. THE PATIENT EXPERIENCED A SUPERFICIAL INFECTION AND DELAY IN HEALING THREE WEEKS POST-OP AND WAS TREATED BY ANTIBIOTIC THERAPY. THE PATIENT IS REPORTED AS WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350285 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention