BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 2113252 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00720
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFLAMMATION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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). IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF INTRAOSSEOUS FOREIGN BODY ON (B)(6) 2011 AND SUTURE WAS USED. ON (B)(6) 2011, THE PATIENT'S WOUND SITE BECAME INFLAMED AND TORE OPEN. THE SURGEON REMOVED THE SUTURE FROM THE PATIENT'S BODY AND PERFORMED DEBRIDEMENT AROUND THE WOUND SITE. THE WOUND SITE WAS TREATED WITH ANTISEPTIC AND GENTISIN OINTMENT WAS APPLIED AND THE WOUND SITE WAS RECOVERING. THE SURGEON SUSPECTED THE EVENT WAS CAUSED BY AN ALLERGIC REACTION TO ABSORBABLE SUTURE, SO ON (B)(6) 2011, THE SURGEON SUTURED THE WOUND SITE WITH A NON-ABSORBABLE SUTURE. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE POSSIBLE BATCH NUMBERS: PRODUCT CODE Z494G, (B)(4), MFG DATE: 12/01/2010, EXP DATE: 07/31/2015. PRODUCT CODE Z494G, (B)(4), MFG DATE: 12/01/2010, EXP DATE: 07/31/2015. PRODUCT CODE Z494G, (B)(4), MFG DATE: 12/01/2010, EXP DATE: 07/31/2015. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF INTRAOSSEOUS FOREIGN BODY ON (B)(6) 2011 AND SUTURE WAS USED. ON (B)(6) 2011, THE PATIENT'S WOUND SITE BECAME INFLAMED AND TORE OPEN. THE SURGEON REMOVED THE SUTURE FROM THE PATIENT'S BODY AND PERFORMED DEBRIDEMENT AROUND THE WOUND SITE. THE WOUND SITE WAS TREATED WITH ANTISEPTIC AND GENTASIN OINTMENT WAS APPLIED AND THE WOUND SITE WAS RECOVERING. THE SURGEON SUSPECTED THE EVENT WAS CAUSED BY AN ALLERGIC REACTION TO ABSORBABLE SUTURE, SO ON (B)(6) 2011, THE SURGEON SUTURED THE WOUND SITE WITH A NON-ABSORBABLE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. NA CH2887

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention