BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB

    MDR report key: 8525265 · Received April 17, 2019

    Report

    Report Number
    1219930-2019-02413
    Event Type
    Injury
    Date Received
    April 17, 2019
    Report Date
    July 26, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    UDI-DI
    10884521045255
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED A PHOTOGRAPHIC EVALUATION OF SEVEN IMAGES OF SURGICAL SITES AND SUTURES. PHOTOGRAPHIC INSPECTION NOTED SUTURED SURGICAL SITES. THE SUTURE IN AN IMAGE WAS OUTSIDE OF THE SURGICAL SITE. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH REGARD TO THE REPORTED CONDITION. ALL OF THE SUTURE PRODUCTS UNDERGO POST PACKAGING STERILITY TESTING. IT IS UNLIKELY THAT THE INFECTION WAS A RESULT OF A MANUFACTURING ACTIVITY. THE INSTRUCTIONS FOR USE (IFU'S) ACTION SECTION STATES: "SUTURES ELICIT MINIMAL ACUTE INFLAMMATORY REACTION IN TISSUE, WHICH IS FOLLOWED BY A GRADUAL ENCAPSULATION OF THE SUTURE BY FIBROUS CONNECTIVE TISSUE. THE WARNING SECTION STATES 1. "USERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING ABSORBABLE SUTURES BEFORE EMPLOYING SUTURES FOR WOUND CLOSURE, AS THE RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE APPLICATION AND THE SUTURE MATERIAL USED." 2. "AS ANY FOREIGN MATERIAL IN THE PRESENCE OF BACTERIAL CONTAMINATION MAY ENHANCE BACTERIAL INFECTIVITY, ACCEPTABLE SURGICAL PRACTICE MUST BE FOLLOWED WITH RESPECT TO DRAINAGE AND CLOSURE OF CONTAMINATED OR INFECTED WOUNDS." 3. "THE USE OF THIS SUTURE MAY BE INAPPROPRIATE IN PATIENTS WITH ANY CONDITIONS WHICH, IN THE OPINION OF THE SURGEON, MAY CAUSE OR CONTRIBUTE TO DELAYED WOUND HEALING." 4. "AS THIS IS AN ABSORBABLE SUTURE MATERIAL, THE USE OF SUPPLEMENTAL NON ABSORBABLE SUTURES SHOULD BE CONSIDERED BY THE SURGEON IN CLOSURE OF THE ABDOMEN, CHEST, JOINTS OR OTHER SITES SUBJECT TO EXPANSION OR REQUIRING ADDITIONAL SUPPORT" ADDITIONALLY, THE ADVERSE REACTIONS SECTION STATES "ADVERSE EFFECTS, WHICH MAY BE ASSOCIATED WITH THE USE OF THIS PRODUCT, INCLUDE: WOUND DEHISCENCE, FAILURE TO PROVIDE ADEQUATE WOUND SUPPORT IN SITES WHERE EXPANSION, STRETCHING, OR DISTENTION OCCUR, FAILURE TO PROVIDE ADEQUATE WOUND SUPPORT CLOSURE IN PATIENTS WITH CONDITIONS WHICH MAY DELAY WOUND HEALING, LOCALIZED IRRITATION WHEN SKIN SUTURES ARE PLACED GREATER THAN 7 DAYS, CALCULI FORMATION WHEN PROLONGED CONTACT WITH SALT SOLUTION OCCURS, ENHANCED BACTERIAL INFECTIVITY, MINIMAL ACUTE INFLAMMATORY REACTION, AND TRANSITORY LOCAL IRRITATION." THE IDENTIFIED HARMS, SEVERITIES AND OCCURRENCE RATES ARE IN ALIGNMENT WITH THE RISK MANAGEMENT FILE . MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT HAD RED SKIN 4-8 WEEKS FOLLOWING AN OPEN SURGICAL PROCEDURE FOR FOOT. IT WAS ALSO STATED THAT SUTURE CAME OUT OF THE SKIN BY ITSELF OR GREW OUT AND MADE INFECTION. THE PATIENT INCURRED A TEMPORARY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315534 POLYSORB SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP LLC NORTH HAVEN GL-323 10884521045255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other