BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERISTEEN ANAL IRRIG SYSTEM

    MDR report key: 8509816 · Received April 12, 2019

    Report

    Report Number
    3006606901-2019-00006
    Event Type
    Injury
    Date Received
    April 12, 2019
    Report Date
    May 9, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    KNT
    PMA / PMN Number
    K112860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS LOT NUMBER IS NOT PROVIDED IT IS IMPOSSIBLE TO TRACE THE RELEVANT PRODUCT DOCUMENTATION AND CHECK IF SIMILAR FAULTS WERE REGISTERED FROM THE PARTICULAR LOT. NO OTHER COMPLAINTS WITH SIMILAR INJURY RECEIVED IN MARCH 2019 FOR THE ITEM NUMBER. THE COMPLAINTS ARE MONITORED FOR A FORMING TREND AND REPORTED TO THE MANAGEMENT ON A REGULAR BASIS. BOWEL PERFORATION ARE COVERED BY THE PRODUCT RISK ASSESSMENT (VV-0051358). AS ROOT CAUSE IS UNDEFINABLE, A SINGLE RISK CANNOT BE SINGLED OUT. TO UNDERLINE THIS, PLEASE FIND ATTACHED THE DOCUMENT "ROOT CAUSE FOR BOWEL PERFORATION OCCURRING IN RELATION TO USE OF PERISTEEN IRRIGATION". CONCLUSION: INTRA-PERITONEAL BOWEL PERFORATION IN CONNECTION WITH THE 3RD PERISTEEN ANAL IRRIGATION (SMALL CATHETER) IN A LARS PATIENT.

    Description of Event or Problem · 0

    THIS CASE CONCERNS A 74 YEARS OLD MALE WITH A RECTAL RESECTION DUE TO COLORECTAL CANCER 7 YEARS AGO. IT IS UNKNOWN WHEN THE PATIENT STARTED USING PERISTEEN ANAL IRRIGATION SYSTEM FOR THE INDICATION OF FECAL INCONTINENCE, BUT THE PATIENT STARTED ON THE ADVICE OF HIS COLORECTAL SURGEON. DURING THE THIRD IRRIGATION WITH 2.5-3 PUMPS AND AFTER 1-LITER INFUSION BY THE PATIENT HIMSELF STANDING UP, THE PATIENT EXPERIENCED INTENSE PAIN AND SEVERE RECTAL BLEEDING AFTER REMOVAL OF THE CATHETER. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED FOR BOWEL PERFORATION AND ACUTE PERITONITIS. THE PATIENT UNDERWENT SURGERY AND HAD A TEMPORARY ILEOSTOMY. ADDITIONAL INFORMATION CONCERNING PATIENT'S MEDICAL TREATMENT : CORTICO-STEROIDS, ALPHA & BETA BLOCKERS AND ANTICHOLESTEROL. DRUGS.

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, A MALE PATIENT WITH LOW ANAL SURGERY SEVERAL YEARS AGO WAS USING PERISTEEN ANAL IRRIGATION SYSTEM. IT IS UNKNOWN WHEN THE PATIENT STARTED PERISTEEN ANAL IRRIGATION BUT IT WAS USED EVERY DAY DURING THE LAST 11 DAYS ON ADVICE FROM THE MEDICAL DOCTOR. THE PATIENT WAS HOSPITALIZED FOR BOWEL PERFORATION. NO MORE INFORMATION WAS REPORTED AT THE TIME OF REPORTING. FOLLOW-UP WITH QUESTIONNAIRE HAS BEEN SENT TO THE PHYSICIAN BY COLOPLAST DUE TO THE VERY LIMITED INFORMATION ON THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304550 PERISTEEN ANAL IRRIG SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COLOPLAST A/S 2912101001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other