BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEALTHY ACCENTS

    MDR report key: 2919838 · Received January 14, 2013

    Report

    Report Number
    1038758-2013-00004
    Event Type
    Other
    Date Received
    January 14, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED COMPLAINT ON (B)(4) 2012 AND MADE A DECISION NOT TO FILE AN MDR. ON 10/22/2012, THE COMPLAINT WAS RE-EVALUATED BASED ON NEW INFORMATION AND A DECISION NOT TO FILE AN MDR WAS MADE BASED ON A CONVERSATION WITH THE END-USER (MALE) WHO STATED THAT NO MEDICAL TREATMENT WAS NECESSARY AND THE INJURED AREAS APPEARED TO BE HEALING. ON (B)(4)2013, MFR RECEIVED NEW INFORMATION FROM THE END-USERS REPORTING THAT THE INJURED AREAS HAVE NOT HEALED. BASED ON THIS NEW INFORMATION, A DECISION WAS MADE TO FILE THE MDR. TEST RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012 CUSTOMER REPORTED THAT THE END-USERS (HUSBAND AND WIFE) CLAIM HAVING BURNS FROM USING THE BANDAGES. ON (B)(4) 2012, MFR CONTACTED THE END-USERS TO OBTAIN MORE INFORMATION. THERE WAS NO RESPONSE TO EITHER INQUIRY. ON 11/02/2012, MFR. SPOKE TO THE END-USER (HUSBAND) WHO SAID THEY DID NOT HAVE TO SEEK MEDICAL ATTENTION, BUT WILL RETURN THE PRODUCT AND WILL SEND SOME PHOTOS. ON 11/02/2012, MFR. HAD NOT RECEIVED ANY PHOTOS OR PRODUCT, SO THE END-USER WAS CONTACTED AGAIN. ON (B)(4) 2013, MFR RECEIVED SOME OF THE PRODUCT RETURNED AND 2 PHOTOS OF THE INJURED AREA ON HIMSELF AND 1 PHOTO OF HIS WIFE. THE END-USER ALSO REPORTED THAT HE HAD CAT SCRATCHES AND USED THE BANDAGES TO COVER THEM. THE TWO PHOTOS OF THE MALE END-USER SHOWS SCRATCH MARKS THAT HAS REDNESS AROUND EACH SCRATCH. THE PHOTO OF THE FEMALE END-USER (WIFE) APPEARS TO SHOW A HEALING AREA.

    Additional Manufacturer Narrative · 2

    MFR REVIEWED COMPLAINT ON (B)(4) 2012 AND MADE A DECISION NOT TO FILE AN MDR. ON 10/22/2012, THE COMPLAINT WAS RE-EVALUATED BASED ON NEW INFORMATION AND A DECISION NOT TO FILE AN MDR WAS MADE BASED ON A CONVERSATION WITH THE END-USER (MALE) WHO STATED THAT NO MEDICAL TREATMENT WAS NECESSARY AND THE INJURED AREAS APPEARED TO BE HEALING. ON (B)(4) 2013, MFR RECEIVED NEW INFORMATION FROM THE END-USERS REPORTING THAT THE INJURED AREAS HAVE NOT HEALED. BASED ON THIS NEW INFORMATION, A DECISION WAS MADE TO FILE THE MDR. TEST RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 2

    ON (B)(6) 2012 CUSTOMER REPORTED THAT THE END-USERS (HUSBAND AND WIFE) CLAIM HAVING BURNS FROM USING THE BANDAGES. ON (B)(4) 2012, MFR CONTACTED THE END-USERS TO OBTAIN MORE INFORMATION. THERE WAS NO RESPONSE TO EITHER INQUIRY. ON 10/22/2012, MFR. SPOKE TO THE END-USER (HUSBAND) WHO SAID THEY DID NOT HAVE TO SEEK MEDICAL ATTENTION, BUT WILL RETURN THE PRODUCT AND WILL SEND SOME PHOTOS. ON 11/02/2012, MFR. HAD NOT RECEIVED ANY PHOTOS OR PRODUCT SO THE END-USER WAS CONTACTED AGAIN. ON (B)(4) 2013, MFR RECEIVED SOME OF THE PRODUCT RETURNED AND 2 PHOTOS OF THE INJURED AREA ON HIMSELF AND 1 PHOTO OF HIS WIFE. THE END-USER ALSO REPORTED THAT HE HAD CAT SCRATCHES AND USED THE BANDAGES TO COVER THEM. THE TWO PHOTOS OF THE MALE END-USER SHOWS SCRATCH MARKS THAT HAS REDNESS AROUND EACH SCRATCH. THE PHOTO OF THE FEMALE END-USER (WIFE) APPEARS TO SHOW A HEALING AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21153 HEALTHY ACCENTS PLASTIC BANDAGES KGX ASO LLC 2543993300 12 12/11 2441-6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other
    2 Other