BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 2063267 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00463
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, 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). RESULT: REPRESENTATIVE SAMPLE OF THE PRODUCT WAS TESTED FOR NEEDLE STRENGTH AND DUCTILITY AND THE RESULTS OBTAINED WERE IN CONFORMANCE WITH THE REQUIREMENTS. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION FOR ENCAPSULATION OF IMPLANT ON (B)(6) 2011 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF NEEDLE BROKE OFF AND APPEARED TO BE IN THE THORACIC CAVITY. THE LOCATION WAS UNABLE TO BE VERIFIED BY XRAY. THE TIP WAS REMOVED AS THE REMAINING PORTION WAS OUTSIDE OF THE CAVITY. THE PATIENT HAD A 30% PNEUMOTHORAX POSTOPERATIVE AND WAS TREATED WITH CHEST TUBE. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2011. A CHEST X-RAY WAS PERFORMED THAT SHOWED A SMALL RESIDUAL PNEUMOTHORAX. NO INTERVENTION PROVIDED. THE PATIENT WAS INSTRUCTED TO CONTINUE DEEP BREATHING EXERCISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA CAP437

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention