BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 3033590 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03425
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INFLAMMATION OCCURRED. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4): REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY EXAMINED. ALL OF THE PACKAGES WERE IN GOOD CONDITION. ALL OF THE SEALS WERE FULL AND COMPLETE WITH NO CHANNELS, SKIPS OR NARROW SEALS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED UNDER THE SKIN AT THE LATERAL CANTHUS. THE PATIENT DEVELOPED A RED AND INFLAMED REACTION AT THE LATERAL CANTHUS. IT STARTED ON THE RIGHT SIDE ABOUT TWO WEEKS POST-OPERATIVELY AND WENT TO THE LEFT SIDE ABOUT 3 WEEKS POST OPERATIVELY. THE PHYSICIAN TREATED THE REACTION WITH A STEROID INJECTION- KENALOG AND THE SYMPTOMS RESOLVED BY (B)(6) 2013

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED UNDER THE SKIN AT THE LATERAL CANTHUS. THE PATIENT DEVELOPED A RED AND INFLAMED REACTION AT THE LATERAL CANTHUS. IT STARTED ON THE LEFT SIDE AND WENT TO BOTH SIDES. THE PHYSICIAN TREATED THE REACTION WITH A STEROID INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136947 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. NA EP2102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention