BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DSM19 4-0 BK MONO NYL 18"/45CM

    MDR report key: 23723191 · Received December 4, 2025

    Report

    Report Number
    3010692967-2025-00108
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    October 2, 2025
    Report Date
    December 4, 2025
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    GAR
    UDI-DI
    00848782010035
    PMA / PMN Number
    K903029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STERILE SAMPLES FROM THE REPORTED LOT, INCLUDING THE ACTUAL DEVICES, WERE NOT RETURNED FOR VISUAL REVIEW OR ANALYSIS. WITHOUT THE ACTUAL REPORTED DEVICES, PHOTOS OF THE DEVICES, OR DETAILED INFORMATION ON THE METHOD USED TO REMOVE THE DEVICE FROM THE PACKAGING, PREOPERATIVE PREPARATION OF THE DEVICE, OR THE SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED FINISHED GOOD LOT AND RAW MATERIAL COMPONENTS IDENTIFIED NO QUALITY ISSUES DURING THE INCOMING, MANUFACTURING, IN-PROCESS, OR FINAL INSPECTION PROCESSES. THE PRODUCT WAS FOUND TO BE MANUFACTURED/INSPECTED ACCORDING TO CRITERIA/PROCEDURE. REVIEW OF LABELING: CONTRAINDICATIONS: DUE TO THE GRADUAL LOSS OF TENSILE STRENGTH WHICH MAY OCCUR OVER PROLONGED PERIODS IN VIVO POLYAMIDE (NYLON) SUTURE SHOULD NOT BE USED WHERE PERMANENT RETENTION OF TENSILE STRENGTH IS REQUIRED. WARNINGS: DO NOT RESTERILIZE. DISCARD OPEN, UNUSED SUTURES AND ASSOCIATED SURGICAL NEEDLES. USERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING POLYAMIDE (NYLON) SUTURE BEFORE EMPLOYING POLYAMIDE (NYLON) SUTURE FOR WOUND CLOSURE, AS THE RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE OF APPLICATION AND THE SUTURE MATERIAL USED. PHYSICIANS SHOULD CONSIDER THE IN VIVO PERFORMANCE (UNDER ACTIONS SECTION) WHEN SELECTING A SUTURE FOR USE IN PATIENTS. THE USE OF THIS SUTURE MAY BE INAPPROPRIATE IN ELDERLY, MALNOURISHED, OR DEBILITATED PATIENTS, OR IN PATIENTS SUFFERING FROM CONDITIONS WHICH MAY DELAY WOUND HEALING. AS WITH ANY FOREIGN BODY, PROLONGED CONTACT OF ANY SUTURE WITH SALT SOLUTIONS, SUCH AS THOSE FOUND IN THE URINARY OR BILIARY TRACTS, MAY RESULT IN CALCULUS FORMATION. ACCEPTABLE SURGICAL PRACTICE SHOULD BE FOLLOWED WITH RESPECT TO DRAINAGE AND CLOSURE OF INFECTED OR CONTAMINATED WOUNDS. PRECAUTIONS: CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID CRUSHING OR CRIMPING THE SUTURE MATERIAL WITH SURGICAL INSTRUMENTS SUCH AS NEEDLE HOLDERS AND FORCEPS. INFECTIONS, ERYTHEMA, FOREIGN BODY REACTIONS, TRANSIENT INFLAMMATORY REACTIONS AND IN RARE INSTANCES WOUND DEHISCENCE ARE TYPICAL OR FORESEEABLE RISKS ASSOCIATED WITH ANY SUTURE AND HENCE ARE ALSO POTENTIAL COMPLICATIONS ASSOCIATED WITH POLYAMIDE (NYLON) SUTURE. ACCEPTABLE SURGICAL PRACTICE MUST BE FOLLOWED WITH RESPECT TO DRAINAGE AND CLOSURE OF INFECTED OR CONTAMINATED WOUNDS. TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT. RESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS RESISTANT TO BENDING AND BREAKING. USERS SHOULD EXERCISE CAUTION WHEN HANDLING SURGICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS. DISCARD USED NEEDLES IN ¿SHARPS¿ CONTAINERS. AS WITH ANY SUTURE MATERIAL, ADEQUATE KNOT SECURITY REQUIRES THE ACCEPTED SURGICAL TECHNIQUE OF FLAT, SQUARE TIES WITH ADDITIONAL THROWS AS WARRANTED BY THE SURGICAL CIRCUMSTANCE AND THE EXPERIENCE OF THE SURGEON. THE USE OF ADDITIONAL THROWS MAY BE PARTICULARLY APPROPRIATE WHEN KNOTTING MONOFILAMENT SUTURES. ADVERSE REACTIONS: ADVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE MAY INCLUDE: WOUND DEHISCENCE; GRADUAL LOSS OF TENSILE STRENGTH OVER TIME; CALCULI FORMATION IN URINARY AND BILIARY TRACTS WHEN PROLONGED CONTACT WITH SALT SOLUTIONS SUCH AS URINE AND BILE OCCURS; INFECTED WOUNDS; MINIMAL ACUTE INFLAMMATORY TISSUE REACTION; AND PAIN EDEMA AND ERYTHEMA AT THE WOUND SITE. BROKEN NEEDLES MAY RESULT IN EXTENDED OR ADDITIONAL SURGERIES OR RESIDUAL FOREIGN BODIES. INADVERTENT NEEDLE STICKS WITH CONTAMINATED SURGICAL NEEDLES MAY RESULT IN THE TRANSMISSION OF BLOODBORNE PATHOGENS. STERILITY: POLYAMIDE (NYLON) IS STERILIZED BY GAMMA RADIATION OR ETHYLENE OXIDE. DO NOT RESTERILIZE. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. DISCARD OPENED UNUSED SUTURES. DO NOT USE AFTER EXPIRATION DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025 THAT WOUND DEHISCENCE OCCURRED POST-OPERATIVELY. TREATMENT REPORTED WAS REMOVAL OF SUTURES AND ANTIBIOTICS. NO OTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157832 DSM19 4-0 BK MONO NYL 18"/45CM A1667N GAR SURGICAL SPECIALTIES CORPORATION A1667N FA23CVX 00848782010035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R