BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL FMS

    MDR report key: 1861950 · Received October 5, 2010

    Report

    Report Number
    2243969-2010-00040
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: ON (B)(6) 2010, MALE PATIENT (B)(6) WAS AND EMERGENCY ADMISSION WITH SUSPECTED ISCHAEMIC BOWEL. LAPAROSCOPY PERFORMED. HERNIATED BOWEL DISCOVERED - MORE INFORMATION TO FOLLOW FULL DETAILS NOT CURRENTLY AVAILABLE. ON (B)(6) 2010, PATIENT RETURNED TO THEATRE FOR REPAIR OF INCARCERATED INCISIONAL HERNIA. THE WOUND FOLLOWING THIS VISIT TO THEATRE FAILED TO HEAL. THE PATIENT'S ABDOMEN IS CURRENTLY OPEN AND HE IS NURSES IN ITU, TAKEN TO THEATRES EVERY 2-3 DAYS FOR DRESSING CHANGE AND IS CURRENTLY ON VAC THERAPY TO ASSIST WOUND CLOSURE. ON (B)(6), THE PATIENT DEVELOPED DIARRHOEA LINKED TO THE BOWEL SURGERY - NOT AND INFECTON - AND FLEXISEAL FMS WAS COMMENCED. THERE IS NO WRITTEN RECORD OF PRE-INSERTION CHECKS OR PR EXAMINATION, BUT THE WARD MANAGER ASSURED ME THAT THIS WILL HAVE BEEN DONE AS THIS IS THE NORMAL PRACTICE ON THE UNIT. SIMILARLY, THE AMOUNT OF WATER IN THE RETENTION BALLOON HAS NOT BEEN RECORDED. THE KIT WAS REMOVED YESTERDAY (B)(6). BECAUSE THE PATIENT'S DIARRHOEA HAS RESOLVED; HOWEVER, IT WAS DISCOVERED THAT THE PATIENT HAD A SMALL AREA OF PRESSURE DAMAGE. THE WOUND IS APPROX 1 CM DIAMETER, SUPERFICIAL AND ON THE SKIN SURFACE SITUATED JUST BELOW THE SACRUM AND BEFORE THE ANUS. (B)(6), THE UNIT MANAGER SUSPECTS THAT THIS EXTERNAL DAMAGE MAY BE PRESSURE DAMAGE SUSTAINED DURING VISITS TO THEATRE FOR DRESSING CHANGE WHERE THE PATIENT MAY HAVE BEEN LYING ON THE TUBE. THERE HAS BEEN NO INTERVENTION OTHER THAN EMOLLIENT THERAPY AND PRESSURE RELIEF, AND THEY ARE HAPPY WITH WOUND PROGRESSION. THEY CONTINUE TO USE FLEXISEL FMS ON THE UNIT UNEVENTFULLY AND CONSIDER THIS TO BE AN ISOLATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KNT CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention PARACETAMOL| PARTOPRAZOB| AMIODARONE| ORONITEL| ENOXAPARIN| TEICOPLANIN| MEROPENEM| SODIUM VALPROATE| FRUSEMIDE| IPRATROPIUM| SALBUTAMOL