BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® CERVICAL RIPENING BALLOON

    MDR report key: 5802595 · Received July 19, 2016

    Report

    Report Number
    1820334-2016-00739
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 24, 2016
    Report Date
    June 27, 2016
    Manufacturer
    COOK INC
    Product Code
    PFJ
    UDI-DI
    00827002481497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 510(K): K131206. EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED DURING THE INVESTIGATION. A PHYSICAL INVESTIGATION WAS DONE ON THE RETURNED COMPLAINT DEVICE. A VISUAL EXAMINATION NOTED THE BALLOON TO HAVE A CIRCUMFERENCE SPLIT. IT IS FEASIBLE TO SUGGEST THE BALLOON WAS OVER INFLATED INITIALLY. THE DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU), WHICH STATES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE INFORMATION PROVIDED, THE ACTUAL ROOT CAUSE IS UNKNOWN AND SO NO CONCLUSION CAN BE DRAWN. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    VAGINA BALLOON WAS GOOD WHEN INJECTED WITH 20ML OF SALINE, BUT AFTER CONTINUING TO INJECT 10ML OF SALINE THE BALLOON RUPTURED AND LEAKED. UPDATED INFORMATION FROM THE REP 28JUNE2016: THE BALLOON RUPTURED CIRCUMFERENTIALLY WHILE WITHIN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457778 COOK® CERVICAL RIPENING BALLOON PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA PFJ COOK INC N/A 00827002481497

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR