BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDSII CLR 27IN 3-0 S/A FS-1

    MDR report key: 9261574 · Received October 31, 2019

    Report

    Report Number
    2210968-2019-89318
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031060975
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DATE SENT TO THE FDA: 02/13/2020. ADDITIONAL INFORMATION: D10, H6. ADDITIONAL H3 DEVICE EVALUATION SUMMARY: THREE SUTURE PIECES OF PRODUCT CODE Z442H WAS RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE USED SUTURE PIECES, BODY FLUIDS AND TISSUE WERE NOTED. THE PRODUCT CODE Z442H IS ABSORBABLE SUTURE AND AT THE TIME OF THE SECOND SURGERY, THE SUTURE WAS ON 103 DAYS OF THE IMPLANTATION AT THIS TIME THE SUTURE WAS FOUND ABSORBED ACCORDING TO THE PERCENTAGE OF THE ORIGINAL STRENGTH, THE PDS II CLEAR DEVICE IS COMPLETELY ABSORBED BY 182 DAYS POST IMPLANTATION. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE BATCH NUMBER IS UNKNOWN. ACCORDING TO THE SAMPLE CONDITION, THE CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? IN WHAT TISSUE LAYER WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION PRE-OP, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WHAT WAS THE TISSUE CONDITION POST-OP, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WHAT WERE THE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? PLEASE CLARIFY AND DESCRIBE WHAT IS MEANT BY ¿TWO EARS PEEL OFF¿? WAS MEDICAL INTERVENTION PROVIDED FOR THE REPORT OF ¿TWO EARS PEEL OFF¿? IF YES, PLEASE DESCRIBE. WHAT WAS THE APPEARANCE OF THE SUTURE DURING REOPERATION ON OCTOBER 3, 2019? ARE PATIENT PHOTOS AVAILABLE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS PRODUCT CODE AND LOT # IF APPLICABLE, WILL THE PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS? EVENTS REPORTED VIA MW 2210968-2019-89317.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT OTOPLASTY ON (B)(6) 2019 AND SUTURE WAS USED FOR PLICATION AND ATTACHMENT OF CONCHA. IN (B)(6) 2019, TWO EARS GOT PEELED OFF. THE PATIENT WAS OPERATED AGAIN ON (B)(6) 2019 AND NO SUTURE WAS FOUND EXCEPT A 3.0 ABSORBABLE SUTURE ON THE RIGHT CONCHA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055690 PDSII CLR 27IN 3-0 S/A FS-1 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. Z442H 10705031060975

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention