BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURAPLY ANTIMICROBIAL WOUND MATRIX

    MDR report key: 7404500 · Received April 6, 2018

    Report

    Report Number
    1221816-2017-00002
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    July 19, 2017
    Report Date
    June 20, 2018
    Manufacturer
    ORGANOGENESIS
    Product Code
    FRO
    UDI-DI
    00618474000039
    PMA / PMN Number
    K051647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL EMDR (FOLLOW-UP REPORT NO. 001) IS TO CORRECT INFORMATION PREVIOUSLY SUBMITTED IN EMDR MFR REPORT #1221816-2017-00002. SPECIFICALLY, THE DEVICE IDENTIFIER PORTION OF THE UNIQUE DEVICE IDENTIFIER (UDI) NUMBER LISTED IN ON THE MEDWATCH FDA FORM 3500A WAS INCORRECT. THE UDI NUMBER ON THE INITIAL EMDR SUBMISSION WAS (B)(4). THIS EMDR PROVIDES THE CORRECT UDI NUMBER FOR THE PRODUCT PURAPLY ANTIMICROBIAL WOUND MATRIX WHICH IS (B)(4). FOR THE INITIAL MDR SUBMISSION THE 'EVENT TYPE' IN H1 OF THE FDA MEDWATCH FORM 3500A WAS LISTED AS 'NO INFORMATION' BECAUSE IT IS UNCLEAR WHETHER THE EVENT THAT OCCURED RESULTED IN A SERIOUS INJURY (THIS WAS UNABLE TO BE ASSESSED DUE TO A LACK OF INFORMATION THAT WAS ABLE TO BE OBTAINED). FOR THIS SUPPLEMENTAL CORRECTION HOWEVER THE OPTION OF 'NO INFORMATION' WAS NOT ABLE TO BE SELECTED FOR 'EVENT TYPE' AND THEREFORE 'SERIOUS INJURY' WAS SELECTED, AS IT WAS THE MOST APPROPRIATE OPTION AVAILABLE (I.E. NO DEATH REPORTED, NO MALFUNCTION REPORTED). THERE ARE NO OTHER CHANGES TO THE INFORMATION CONTAINED IN THE INITIAL MDR SUBMISSION #1221816-2017-00002.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED SUGGESTS THAT IT IS POSSIBLE THAT THE INFECTION MAY HAVE BEEN RELATED TO THE APPLICATION OF PURAPLY AM, HOWEVER LIMITED INFORMATION IS AVAILABLE ABOUT THE EVENT. INFECTION IN WOUNDS CAN BE CAUSED BY A MULTITUDE OF DIFFERENT FACTORS AND ALTHOUGH ENTEROBACTER SPECIES CAN CAUSE SKIN AND SOFT TISSUE INFECTIONS, RECENT TRENDS DISTINGUISH ITS INCREASING ROLE IN INSTITUTIONALLY ACQUIRED WOUND INFECTIONS AND THE OCCURRENCE OF SKIN AND SOFT TISSUE INFECTIONS IN PREVIOUSLY HEALTHY INDIVIDUALS IN THE COMMUNITY, OCCASIONALLY AS A RESULT OF MULTIPLE RESISTANT STRAINS. PREVIOUSLY SUBMITTED SEP 13, 2017, BUT FAILED FINAL ACKNOWLEDGEMENT, FOUND DURING FILE CLOSURE ACTIVITIES.

    Description of Event or Problem · 1

    THE PATIENT HAD PURAPLY AM APPLIED TO A WOUND (UNKNOWN LOCATION, UNKNOWN ETIOLOGY) ON (B)(6) 2017. AT THE TIME OF THE APPLICATION, THE WOUND PRESENTED WITH SOME ERYTHEMA, BUT WAS NOT INFECTED AND BONE/TENDON WAS NOT EXPOSED. THE WOUND WAS FREE OF DEBRIS AND NECROTIC TISSUE. PURAPLY AM WAS PLACED DRY AND THEN REHYDRATED AND IN CONTACT WITH THE WOUND BED, COVERED WITH MEPITEL. THE PATIENT WAS TOLD TO FOLLOW UP IN ONE WEEK. ON THE PATIENTS FOLLOW UP VISIT ON (B)(6) 2017, INFECTION WAS NOTED AS PERI WOUND ERYTHEMA, INCREASE IN WOUND SIZE AND CULTURES REVEALING ENTEROBACTER SPECIES. ADDITIONAL INFORMATION ABOUT THE WOUND, THE CURRENT STATUS OF THE PATIENT AND OUTCOME IS UNKNOWN. WHETHER ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED IS UNKNOWN AND WHETHER THE PRODUCT WAS REMOVED OR REAPPLIED IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245461 PURAPLY ANTIMICROBIAL WOUND MATRIX PURAPLY ANTIMICROBIAL WOUND MATRIX FRO ORGANOGENESIS 1 AM170417.1.1D 00618474000039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other