BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILVERLON

    MDR report key: 3251076 · Received July 24, 2013

    Report

    Report Number
    1065238-2013-00001
    Event Type
    Other
    Date Received
    July 24, 2013
    Date of Event
    January 16, 2002
    Report Date
    July 15, 2013
    Manufacturer
    ARGENTUM MEDICAL
    Product Code
    FRO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT (B)(4) IS BASED ON OUR RETROSPECTIVE ROOT CAUSE INVESTIGATION. THE FDA HAS NOT REQUESTED WE CONDUCT THIS INVESTIGATION AND IT IS NOT REQUIRED BY SECTION 522 OF THE ACT. OUR INVESTIGATION INCLUDED: INTERVIEWING THE PHYSICIAN THAT SUBMITTED THE REPORT, A SEARCH OF ALL COMPLAINT RECORDS, A SEARCH OF THE MAUDE DATABASE, LITERATURE REVIEW, OUR MEDICAL DIRECTOR'S REVIEW INCLUDED CONTACTING OTHER PRACTICING PHYSICIAN EXPERTS LIKELY TO HAVE TREATED SIMILAR CASES. RESULTS OF OUR INVESTIGATION: THE REPORTING PHYSICIAN IN RECALLING THE CASE SAID ALTHOUGH HE DID NOT RECOLLECT MANY SPECIFICS OF THE CASE, HE CONTINUED TO USE SILVERLON WITH NO REPEATED INCIDENTS. HE WAS SURE OF THIS BECAUSE IF HE HAD THEY WOULD HAVE BEEN REPORTED TO FDA. THE REVIEW OF POSTMARKETING SURVEILLANCE DATA IS ABSENT IN ANY OTHER REPORTS OF PTS EXPERIENCING PAIN WHEN UNDERGOING MRI SINCE THE PRODUCT WAS CLEARED TO MARKET. (B)(4), THE FACT THAT NO OTHER ADVERSE EVENTS OR SIMILAR PRODUCT COMPLAINTS HAVE BEEN REPORTED IS SIGNIFICANT. FURTHERMORE, CHAUDHRY ASSESSED THE SAFETY AND COMPATIBILITY OF SILVER BASED WOUND DRESSING IN A MAGNETIC RESONANCE ENVIRONMENT. SILVERLON WAS ONE OF THREE SILVER DRESSINGS EVALUATED. THE STUDY, CONCLUDED THAT EVEN IN AN ULTRA HIGH FIELD 7T MRI SCANNED THE DRESSINGS WERE SAFE AND COMPATIBLE WITH MRI SCANNING. BASED ON THE INFO AVAILABLE AT THIS TIME, THE ROOT CAUSE OF THE PT COMPLAINT OF PAIN DURING MRI CAN'T BE DETERMINED. HOWEVER, BASED ON THE TOTALITY OF EVIDENCE WE CONCLUDE THE DEVICE MET SPECS AND DID NOT MALFUNCTION. THE ARGENTUM MEDICAL DIRECTOR HAS REVIEWED THE DATA COLLECTED IN THIS RETROSPECTIVE INVESTIGATION AND CONCLUDED SILVERLON DRESSINGS ARE COMPATIBLE WITH MRI. AN INDEPENDENT STUDY WAS CONDUCTED AT (B)(4) UNIV IN FEBRUARY 2009 SILVERLON AND TWO OTHER SILVER DRESSINGS. THE PURPOSE OF THE STUDY WAS TO DETERMINE WHETHER THE SILVER DRESSINGS PRODUCED MRI IMAGE DISTORTION OR IF THE AGITATION OF THE SILVER PARTICLES GENERATES ENOUGH HEAT WHICH MIGHT PRODUCE FURTHER SKIN DAMAGE. THE STUDY CONCLUDED: "THE THREE SILVER DRESSINGS TESTED IN THIS STUDY SHOWED MINIMAL NEGATIVE INTERACTIONS WITH MRI SCANNING. SIGNIFICANT IMAGE DISTORTIONS WERE NOT ENCOUNTERED AND NO TEMPERATURE INCREASES WERE NOTED IN AN ULTRA HIGH FIELD 7T MRI SCANNER."

    Description of Event or Problem · 1

    ON (B)(6) 2013, PHYSICIAN DID RECOLLECT THE INCIDENT. HE DID NOT RECALL SPECIFICS. HE DID NOT RECALL THE SURROUNDING HEALTH OR THE LOCATION OF THE WOUND. HE DID RECALL THE PT DID NOT HAVE A LASTING INJURY. PT EXPERIENCED BURNING PAIN DURING MRI BUT STOPPED WHEN SCAN WAS DONE. THE LEVEL OF RESONANCE BEING USED IS NOT DOCUMENTED. THE FACILITY THAT INITIATED REPORT DID NOT DESCRIBE THE PROTOCOL FOR TESTING. SURROUNDING THERAPY(IES) WERE NOT DESCRIBED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344381 SILVERLON CONTACT WOUND DRESSING FRO ARGENTUM MEDICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other