BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PALS

    MDR report key: 6750117 · Received July 28, 2017

    Report

    Report Number
    1213643-2017-00469
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Report Date
    November 22, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    NBE
    UDI-DI
    00801741010026
    PMA / PMN Number
    P010047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW OF DAVOL¿S MDR DECISIONS AND THE INITIAL DECISION NOT TO REPORT THE EVENT IS BEING REVISED TO REFLECT UPDATED COMPANY PROCEDURES. THE SUBJECT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE REVIEW OF THE DHR DID NOT SHOW ANY DEVIATIONS OR NONCONFORMANCES THAT COULD HAVE LED TO THIS EVENT. LABEL RECONCILIATION SHOWS THAT ONLY THE 130513-002 LABELS WITH AN EXPIRATION DATE OF JAN-2015 WERE USED IN THE PRODUCTION LOT. BASED ON THE LIMITED INFORMATION PROVIDED, NO CONNECTION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE DAVOL PRODUCT IN QUESTION. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. DISCARDED.

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW OF DAVOL¿S MDR DECISIONS AND THE INITIAL DECISION NOT TO REPORT THE EVENT IS BEING REVISED TO REFLECT UPDATED COMPANY PROCEDURES. THE SUBJECT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE REVIEW OF THE DHR DID NOT SHOW ANY DEVIATIONS OR NONCONFORMANCES THAT COULD HAVE LED TO THIS EVENT. LABEL RECONCILIATION SHOWS THAT ONLY THE (B)(4) LABELS WITH AN EXPIRATION DATE OF JAN-2015 WERE USED IN THE PRODUCTION LOT. BASED ON THE LIMITED INFORMATION PROVIDED, NO CONNECTION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE DAVOL PRODUCT IN QUESTION. THIS SUPPLEMENTAL MDR IS SUBMITTED TO ADD MISSING CONCLUSION CODES.

    Description of Event or Problem · 1

    CONTACT REPORTS THAT THE EXPIRATION DATE ON THE PROGEL OUTER CARTON IS DIFFERENT THAN THE INNER PACKAGE. REQUESTED TO KNOW IF THIS IS CORRECT AND WHICH WOULD BE THE DATE TO GO BY. CONTACT INFORMED THAT PRODUCT SHOULD CONTAIN A LOT NUMBER AND EXPIRATION DATE THAT IS THE SAME AT EACH LEVEL OF PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530392 PROGEL PALS PROGEL PALS, 4ML, US NBE DAVOL INC., SUB. C.R. BARD, INC. NA 130513-002 00801741010026

    Patients

    Seq Age Sex Outcome Treatment
    1