BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFX SPI PDS+ UNI 18IN 3-0 SA PS-2 PRM

    MDR report key: 11899069 · Received May 27, 2021

    Report

    Report Number
    2210968-2021-05062
    Event Type
    Injury
    Date Received
    May 27, 2021
    Report Date
    May 17, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031236257
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN AND CLARIFY THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? DATE OF INDEX SURGERY? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? IT WAS REPORTED ¿IT MAY BE A PROBLEM WITH THE SUTURING TECHNIQUE¿. CAN YOU SPECIFY THIS SUTURING TECHNIQUE? INTERRUPTED OR CONTINUOUS? WAS FIXATION LOOP SECURED TO TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE? WAS AT LEAST ONE REVERSE STITCH PERFORMED PRIOR TO CLOSURE? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFLAMMATION PRIOR TO THIS SURGICAL PROCEDURE? WERE ANY PRE-OP CLEANSING PROCEDURES OR PRODUCTS CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE OR DURING THE SUTURE PLACEMENT? WHAT DATE DID THE PATIENT PRESENT WITH REDDISH WOUND AND DEVICE PROTRUSION/EXTRUSION ( # OF POST-OP DAYS)? OTHER RELEVANT PATIENT COMORBIDITIES/CONCOMITANT MEDICATIONS? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS? WAS THE ¿REDDISH¿ RESOLVED AFTER SUTURE PROTRUDING PART REMOVAL? TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH = 2360 G/M.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE FOR SCOLIOSIS ON UNKNOWN DATE AND THE BARBED SUTURE WAS USED IN DERMAL MATTRESS SUTURE. IT WAS REPORTED THAT DURING HOSPITALIZATION, THE BARBED SUTURE PROTRUDED FROM THE WOUND. WHILE A YOUNG PATIENT WITH SCOLIOSIS WAS ADMITTED TO THE HOSPITAL, THE WOUND APPEARED REDDISH. THE PROTRUDING PART WAS EXCISED, AND THE EPIDERMIS WAS SUTURED. THE SURGEON OPINED THAT THE CAUSAL RELATIONSHIP BETWEEN THE SUTURE AND THE EVENT IS UNKNOWN AND IT MAY BE A PROBLEM WITH THE SUTURING TECHNIQUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794997 SFX SPI PDS+ UNI 18IN 3-0 SA PS-2 PRM SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. SXPP1B105 10705031236257

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention