BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADEPT ADHESION REDUCTION SOLUTION

    MDR report key: 3262603 · Received August 2, 2013

    Report

    Report Number
    2032282-2013-00067
    Event Type
    Injury
    Date Received
    August 2, 2013
    Date of Event
    May 1, 2011
    Report Date
    July 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - VIENNA
    Product Code
    MCN
    PMA / PMN Number
    P050011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT SUMMARY: INTRA-OPERATIVE INSTILLATION OF UP TO 1-LITER OF ANY LIQUID IN THE PERITONEAL CAVITY IS KNOWN TO RESULT IN LOCAL MECHANICAL EFFECTS, INCLUDING AN ABDOMINAL DISCOMFORT, ABDOMINAL PAIN, AND URINARY RETENTION. THIS MAY OCCASIONALLY RESULT IN PROLONGATION OF THE USUAL, ROUTINE HOSPITAL STAY. ADEPT MAY CAUSE OR CONTRIBUTE TO THE OCCURRENCE OF POSTOPERATIVE ABDOMINAL PAIN (DUE TO ABDOMINAL DISTENSION). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER VIENNA HAS COMPLETED THE INVESTIGATION. SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED AS NO SAMPLE OR LOT NUMBER WAS AVAILABLE. NO TREND WAS IDENTIFIED. PER VIENNA, THE COMPLICATION IS DISCUSSED IN THE MEDICAL ASSESSMENT AND NO FURTHER INVESTIGATION IS REQUIRED AS IT CANNOT BE DETERMINED IF THE USE OF ADEPT CAUSED THE COMPLAINT. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    FROM LITERATURE: NESBITT-HAWES, ERIN M ET AL. "URINARY RETENTION FOLLOWING LAPAROSCOPIC GYNAECOLOGICAL SURGERY WITH OR WITHOUT 4% ICODEXTRIN ANTI-ADHESION SOLUTION." AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY 2013; 53: 305-309. ABSTRACT: BACKGROUND: URINARY RETENTION IS A RECOGNIZED COMPLICATION OF LAPAROSCOPIC SURGERY. PREVIOUS WORK SHOWED AN ASSOCIATION WITH 4% ICODEXTRIN SOLUTION AND URINARY RETENTION. AIMS: TO DETERMINE THE INCIDENCE OF URINARY RETENTION FOLLOWING LAPAROSCOPIC GYNAECOLOGICAL SURGERY WITH OR WITHOUT THE USE OF 4% ICODEXTRIN. METHODS: A PROSPECTIVE OBSERVATIONAL STUDY OF 147 WOMEN UNDERGOING LAPAROSCOPIC GYNAECOLOGICAL SURGERY FOR BENIGN PATHOLOGY. WOMEN HAD THEIR PLANNED LAPAROSCOPIC PROCEDURE AND EITHER RECEIVED ICODEXTRIN SOLUTION OR NOTHING AS DETERMINED BY THEIR TREATING SURGEON AT THE TIME OF THE OPERATION. RESULTS: FROM MAY 2011 TO FEBRUARY 2012, 147 WOMEN WERE APPROACHED TO PARTICIPATE IN THE STUDY; OF WHOM, 124 WOMEN WERE INCLUDED: 62 RECEIVED ICODEXTRIN AND 62 DID NOT. THE WOMEN IN THE NON-ICODEXTRIN GROUP WERE SIGNIFICANTLY OLDER (P = 0.007) AND HAD A HIGHER BMI (P = 0.03) THAN THOSE IN THE ICODEXTRIN GROUP. FOLLOWING SURGERY, 27/124 (21.8%) WOMEN HAD POST-OPERATIVE URINARY RETENTION. ICODEXTRIN WAS ASSOCIATED WITH SIGNIFICANTLY MORE URINARY RETENTION (P = 0.017), BUT DID NOT EXTEND HOSPITAL ADMISSION SIGNIFICANTLY (P = 0.14). THE ADMINISTRATION OF ICODEXTRIN WAS ASSOCIATED WITH RESECTION OF MODERATE- OR SEVERE-STAGE ENDOMETRIOSIS INVOLVING MULTIPLE SURGICAL SITES, WHEREAS WOMEN IN THE NON-ICODEXTRIN GROUP WERE MORE LIKELY TO BE HAVING A HYSTERECTOMY. CONCLUSIONS: IN THIS NON-RANDOMIZED STUDY, THERE WERE SIGNIFICANTLY MORE WOMEN WITH POST-OPERATIVE URINARY RETENTION WHEN ICODEXTRIN WAS USED; HOWEVER, THIS DID NOT CONTRIBUTE TO AN EXTENDED HOSPITAL ADMISSION. WHILE THERE MAY BE CONFOUNDING FACTORS, WOMEN RECEIVING ICODEXTRIN SHOULD BE WARNED OF THE POSSIBILITY OF URINARY RETENTION POST-OPERATIVELY, BUT THAT THIS IS UNLIKELY TO AFFECT THEIR STAY IN HOSPITAL. ABDOMINAL PAIN CAUSING PROLONGED HOSPITALIZATION PATIENT 2: UPON REVIEW OF THE ARTICLE, IT WAS IDENTIFIED TWO PATIENTS EXPERIENCED PROLONGED HOSPITALIZATION DUE TO ABDOMINAL PAIN. THIS IS ONE OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363791 ADEPT ADHESION REDUCTION SOLUTION BARRIER, ABSORABLE, ADHESION MCN BAXTER HEALTHCARE - VIENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O