BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 2010625 · Received February 24, 2011

    Report

    Report Number
    2210968-2011-00201
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 02/24/2011. (B)(4) - AMYLASE LEVEL RAISED. (B)(4) - WOUND DEHISCENCE OCCURRED. 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. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH CEM632, MFG DATE: 05/01/2010, EXP DATE: 01/31/2015. BATCH CH6783, MFG DATE: 07/01/2010, EXP DATE: 07/31/2015. BATCH CJM322, MFG DATE: 08/01/2010, EXP DATE: 07/31/2015. BATCH CKM759, MFG DATE: 09/01/2010, EXP DATE: 07/31/2015. BATCH CLK113, MFG DATE: 10/01/2010, 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 GOOD RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT PANCREATOJEJUNOSTOMY AND CHOLEDOCHOJEJUNOSTOMY PROCEDURES ON (B)(6) 2011. SUTURE WAS USED WITH A KNOTTED SUTURING TECHNIQUE ON THE PANCREATIC DUCTS, INTESTINAL ANASTOMOSIS SITES AND THE BILE DUCTS. SIX DAYS LATER, AFTER THE SURGEON REMOVED THE DRAIN FROM THE PATIENT'S BODY, THE AMYLASE LEVEL WAS MARKEDLY RAISED. THE SURGEON SUSPECTED THAT THE SUTURE SITE MAY BE DEHISCED. THE SURGEON OPINES THAT THE SUTURE BROKE OR THE KNOTS UNTIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention