BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMATRIX 18 MM DISC

    MDR report key: 18529183 · Received January 17, 2024

    Report

    Report Number
    3004170064-2024-00004
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    January 5, 2023
    Report Date
    July 12, 2024
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    KGN
    PMA / PMN Number
    K153690
    Removal / Correction Number
    3004170064-05/23/2023-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRIMATRIX (ID (B)(6)) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    PLACEMENT DATE: ON (B)(6) 2022. PATIENT HEALTH EFFECT AND DATE: WOUND SLIGHTLY MORE PALE THIS WEEK TREATMENT: 11/10 - THE WOUND WAS DEBRIDED AND PREPPED FOR THE PRIMATRIX APPLICATION. AFTER THE APPLICATION, THE SITE WAS COVERED WITH SILVER ALGINATE AND AN ALLEVYN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: QUESTION: FOR OUR DOCUMENTATION, CAN YOU PLEASE ADVISE WHY THERE WAS A DELAY IN SUBMITTING THE MEDWATCH FORMS FOR THE VARIOUS PRIMATRIX COMPLAINTS REPORTED IN NOVEMBER OF 2023. SOME COMPLAINTS DATE BACK AS FAR AS 2019, BUT ALL COMPLAINTS WERE REPORTED AT THE SAME TIME IN NOVEMBER 2023. WAS THIS DUE TO THE RECALL? ANSWER: "YES. THIS WAS DUE TO THE INTEGRA RECALL." FDA RECALL NUMBER: RES#: 92481.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: H1. UPDATED FIELDS: G3, G6, H7, H9, H11.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: G3, G6, H2, H10. CORRECTED FIELD: H9.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    MEDWATCH # MW5148672 THIS IS 1 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3004170064-2024-00005, 3004170064-2024-00006, 3004170064-2024-00007. A FACILITY REPORTED: "11/10-RIGHT MEDIAL HEEL, RIGHT LATERAL HEEL PRESSURE/DIABETIC ULCERS- WOUND DEBRIDED AND PRIMATRIX #1 PLACED 11/17-WOUND SLIGHTLY MORE PALE THIS WEEK. PRIMATRIX #2 PLACED 11/22- GRAFT LEFT IN PLACE-RESTORE VEIL WAS REPLACED AND SECURED WITH STERISTRIPS." "12/8- MACERATED CALLUS BUILDUP BUT WOUND BASE PINK WITH A BIT OF BIOFILM. DEBRIDEMENT AND PRIMATRIX #3 PLACED." "ON 2022- DIABETIC ULCER OF RIGHT FOOT ASSOCIATED WITH DM 2 WITH FAT LAYER EXPOSED. FIRST PRIMATRIX PLACED 11/10; WOUND BASE MORE RED. PRIMATRIX PLACED. 12/29- SUPERIOR ASPECT OF THE WOUND EDGE HAS AN EXTENDED AREA OF ULCERATION. PRIMATRIX PLACED (#5) ON 2023- WOUND LARGER- TREATMENT PLAN CHANCED- SILVER ALGINATE; CULTURESERRATIA MARCESCENS; KLEBSIELLA PNEUMONIAE, E. FAECALIS. 1/19- WOUND IMPROVED AND WOUND CONTINUED TO IMPROVE. NO FEVER IDENTIFIED DURING VISITS." EVENT: "PRIMATRIX #1 PLACED 11/17-WOUND SLIGHTLY MORE PALE THIS WEEK."

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404629 PRIMATRIX 18 MM DISC PRIMATRIX KGN TEI BIOSCIENCES INC 2111016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown