BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 2070911 · Received April 27, 2011

    Report

    Report Number
    2210968-2011-00518
    Event Type
    Injury
    Date Received
    April 27, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT AFTER THE INITIAL PROCEDURE, THE PATIENT EXPERIENCED PROLONGED ATONY. AFTER STIMULATION, THE PATIENT WAS DISCHARGED. ON (B)(6) 2011 THE PATIENT RETURNED WITH SEPSIS. COMPUTER TOMOGRAPHY INDICATED A BIG ABSCESS. THE PATIENT UNDERWENT IMMEDIATE RE-LAPAROTOMY AND EROSION OF SMALL INTESTINE CAUSED BY METAL STRING. THE PATIENT UNDERWENT ABSCESS DRAINAGE, RESECTION OF A PART OF THE SMALL INTESTINE, AND CLOSURE OF ABDOMINAL WALL WITH LOOP. CURRENTLY, THE PATIENT'S CONDITION IS FINE. POSTOPERATIVE ATONY. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH CD6834 MFG DATE: 04/01/2010, EXP DATE: 01/01/2012. BATCH CEZ175 MFG DATE: 05/01/2010, EXP DATE: 01/31/2012. BATCH CHM028 MFG DATE: 07/01/2010, EXP DATE: 01/31/2012. BATCH CH6717 MFG DATE: 07/01/2010, EXP DATE: 01/31/2012. BATCH CJ6089 MFG DATE: 08/01/2010, EXP DATE: 07/31/2012. BATCH CKM042 MFG DATE: 09/01/2010, EXP DATE: 07/31/2012. BATCH DA6115 MFG DATE: 01/01/2011, EXP DATE: 01/31/2013. BATCH DA6746 MFG DATE: 01/01/2011, EXP DATE: 01/31/2013. BATCH DA6747 MFG DATE: 01/01/2011, EXP DATE: 01/31/2013. 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 RIGHT HEMICOLECTOMY ON AN UNKNOWN DATE AND THE ABDOMINAL WALL FASCIA WAS CLOSED WITH SUTURE. THE PATIENT WAS DISCHARGED FREE OF PAIN TO GO TO A HEALTH RESORT. AFTER THE PATIENT ARRIVED THERE, THE PATIENT HAD TO GO TO ANOTHER HOSPITAL DUE TO PAIN AND WAS DIAGNOSED WITH A BURST ABDOMEN. THE PATIENT UNDERWENT A RE-OPERATION ON (B)(6) 2011. THE SURGEON REPORTED THAT HE FOUND THAT THE SUTURE HAD SPLICED LENGTHWISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS LL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE NEW ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention