BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONTOSAN®

    MDR report key: 14053129 · Received April 8, 2022

    Report

    Report Number
    3007120504-2022-00002
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 8, 2022
    Manufacturer
    B.BRAUN MEDICAL AG
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL AG INTERNAL REPORT NUMBER (B)(4). COMPLAINT SAMPLE WAS ANALYSED IN LOCAL QUALITY CONTROL DEPARTMENT. THE FOLLOWING PARAMETERS WERE CHECKED: APPEARANCE, RELATIVE DENSITY, PH-VALUE, OSMOLALITY, ENDOTOXINES, ID AND ASSAY OF POLIHEXANIDE, AND REFRACTION. ALL PARAMETERS WERE WITHIN THE SPECIFICATION. THEREFORE, NO DEVICE MALFUNCTION IDENTIFIED. FURTHTERMORE, THE BATCH DOCUMENT WAS CHECKED. THE FOLLOWING DEVIATIONS WERE REPORTED: (B)(4): LEAKAGE OF CONTAINER, NO RISK BECAUSE AFFECTED PRODUCTS WERE DISCARDED. (B)(4): UNDERFILLING OF CONTAINER, NO RISK BECAUSE AFFECTED PRODUCTS WERE DISCARDED. CONCLUSION: REPORTED DEVIATIONS HAVE NO IMPACT ON PRODUCT SAFETY. THE INSTRUCTIONS FOR USE OF THE PRODUCT HAVE BEEN CHECKED AND THE FOLLOWING SIDE EFFECTS ARE LISTED: "IN VERY RARE CASES, THERE MAY BE A MILD BURNING SENSATION AFTER APPLICATION OF PRONTOSAN, BUT THIS USUALLY DISSIPATES AFTER A FEW MINUTES. PRONTOSAN CAN CAUSE ALLERGIC REACTIONS SUCH AS ITCHING (URTICATIA) AND RASHES (EXANTHEMA). IN RARE CASES (LESS THAN 1 OUT OF 10,000), ANAPHYLACTIC SHOCK HAS BEEN REPORTED.". (B)(4). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY PATIENT PRESENTED WITH PERI-ANAL FISTULAE, DISINTEGRATING PERINEUM WITH EXTENSIVE BUTTOCK ABSCESSES TRACKING INBETWEEN THE RIGHT GLUTEOUS MUSCLES WHICH WERE IRRIGATED WITH 200ML PRONTOSAN SOLUTION. PATIENT DEVELOPED GENERALISED URTICARIA, FOLLOWED BY A CARDIO-PULMONARY ARREST. AFTER ONE CYCLE OF CPR AND ADMINISTRATION OF ADRENALINE, THE PATIENTS' PULSE RETURNED. FOLLOWING MEDICATIONS GIVEN: AUGMENTIN; PANADO; TRAMAL; ARV'S; SEVOFLUORANE; FENTANYL; ROCURONIUM; ADRENALINE; DEXAMETHASONE. SEVERE CARDIO-RESPIRATORY COLLAPSE LASTED APPROXIMATELY 5 MINS AND MODERATE URTICARIA EPISODE 2 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161656 PRONTOSAN® PRONTOSAN WOUND IRRIGATION SOLUTION, FRO B.BRAUN MEDICAL AG 21053M13

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention| H| L