BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 12442650 · Received September 8, 2021

    Report

    Report Number
    1213643-2021-20316
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 3, 2024
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    PMA / PMN Number
    P010047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PROGEL PALS WAS STORED AT A TEMPERATURE BELOW THE PROPER STORAGE CONDITIONS PER THE INSTRUCTIONS-FOR-USE. THE PRODUCT PERFORMED AS INTENDED AND THERE WAS NO PATIENT INJURY. THE COMPLAINT IS CONFIRMED AS A USE RELATED ISSUE, AS THE USER REPORTED THE EVENT TO US AND IS AWARE THAT THE PRODUCT SHOULD BE STORED IN REFRIGERATED CONDITIONS AND NOT STORED IN A FREEZER. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS THAT, "PROGEL¿ PALS SHOULD BE REFRIGERATED BETWEEN 2°C AND 8°C (36°F TO 46°F). DO NOT FREEZE. STORE PROGEL¿ PALS WITHIN THE RECOMMENDED TEMPERATURE RANGE. FAILURE TO DO SO MAY RESULT IN POOR PRODUCT PERFORMANCE." NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS 17-AUG-2021 BASED ON DATE OF AWARENESS. ADDENDUM: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT MEDICAL DEVICE MANUFACTURER. UPDATED FIELDS: B4, G3, G4, G6, H2, H10, H11 CORRECTED FIELDS: D3 (MANUFACTURER) NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD ACCIDENTLY STORED THE PROGEL PLEURAL AIR LEAK SEALANT (PALS) IN A FREEZER WHICH HAD TEMPERATURE OF -24°F. (PER THE INSTRUCTIONS-FOR-USE THIS PRODUCT SHOULD BE ¿REFRIGERATED BETWEEN 2°C AND 8°C (36°F AND 46°F). DO NOT FREEZE. NOTE: STORE PROGEL¿ PALS WITHIN THE RECOMMENDED TEMPERATURE RANGE. FAILURE TO DO SO MAY RESULT IN POOR PRODUCT PERFORMANCE.¿) AS REPORTED, THE PRODUCT HAD BEEN USED ON A PATIENT. THE CUSTOMER REPORTS THAT THE PRODUCT PERFORMED AS INTENDED, WHEN USED IN THE PROCEDURE AND THERE WAS NO PATIENT ADVERSE EVENT AS A RESULT.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PROGEL PALS WAS STORED AT A TEMPERATURE BELOW THE PROPER STORAGE CONDITIONS PER THE INSTRUCTIONS-FOR-USE. THE PRODUCT PERFORMED AS INTENDED AND THERE WAS NO PATIENT INJURY. THE COMPLAINT IS CONFIRMED AS A USE RELATED ISSUE, AS THE USER REPORTED THE EVENT TO US AND IS AWARE THAT THE PRODUCT SHOULD BE STORED IN REFRIGERATED CONDITIONS AND NOT STORED IN A FREEZER. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS THAT, "PROGEL¿ PALS SHOULD BE REFRIGERATED BETWEEN 2°C AND 8°C (36°F TO 46°F). DO NOT FREEZE. STORE PROGEL¿ PALS WITHIN THE RECOMMENDED TEMPERATURE RANGE. FAILURE TO DO SO MAY RESULT IN POOR PRODUCT PERFORMANCE." NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS (B)(6) 2021 BASED ON DATE OF AWARENESS. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD ACCIDENTLY STORED THE PROGEL PLEURAL AIR LEAK SEALANT (PALS) IN A FREEZER WHICH HAD TEMPERATURE OF -24°F. (PER THE INSTRUCTIONS-FOR-USE THIS PRODUCT SHOULD BE ¿REFRIGERATED BETWEEN 2°C AND 8°C (36°F AND 46°F). DO NOT FREEZE. NOTE: STORE PROGEL¿ PALS WITHIN THE RECOMMENDED TEMPERATURE RANGE. FAILURE TO DO SO MAY RESULT IN POOR PRODUCT PERFORMANCE.¿) AS REPORTED, THE PRODUCT HAD BEEN USED ON A PATIENT. THE CUSTOMER REPORTS THAT THE PRODUCT PERFORMED AS INTENDED, WHEN USED IN THE PROCEDURE AND THERE WAS NO PATIENT ADVERSE EVENT AS A RESULT. THIS REPORT IS BEING SUBMITTED AS FAILURE TO FOLLOW THE PROPER STORAGE CONDITIONS PER THE INSTRUCTIONS-FOR-USE COULD RESULT IN THE PRODUCT NOT PERFORMING AS INTENDED AND A MALFUNCTION OF THIS NATURE COULD RESULT IN THE NEED FOR INTERVENTION DUE TO THIS USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339896 PROGEL PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other