BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID BRAND WATER BLOCK CLEAR ADHESIVE BANDAGES

    MDR report key: 3070063 · Received April 22, 2013

    Report

    Report Number
    8041154-2013-00005
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 7, 2013
    Manufacturer
    BRAZIL CONSUMER
    Product Code
    KGX
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) 2013, FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (BAB WATERBLOCK PLUS LARGE 2.9X2IN 10S). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) 2013, FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (BAB WATERBLOCK PLUS LARGE 2.9X2IN 10S). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING FOR SELF FROM CANADA. THE MEDICAL HISTORY INCLUDED UNSPECIFIED MAJOR SURGERY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING BAND AID BRAND WATER BLOCK CLEAR ADHESIVE BANDAGES CUTANEOUSLY TO PROTECT THE STITCHES FROM A MAJOR SURGERY (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE NOTICED THAT TWO OF HER STITCHES GOT INFECTED AS THE BAND AID DID NOT WORK PROPERLY. SHE STATED THAT SHE WAS LAYING DOWN IN PAIN FROM HAVING TO REDO HER SURGERY TWICE TO GET THE STITCHES PUT BACK AS SHE HAD TO GET THE INFECTION TAKEN CARE OF. THE ACTION TAKEN WITH THE DEVICE AND THE OUTCOME OF EVENT WERE UNKNOWN. THE CONSUMER DID NOT REPORT A SPECIFIC LOT NUMBER; THEREFORE, LOT TRENDING OR FURTHER INVESTIGATION COULD NOT BE PERFORMED. FAMILY TREND ANALYSIS WAS CONDUCTED FOR THIS COMPLAINT. A REVIEW OF THE COMPLAINT DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY DID NOT IDENTIFY AN ADVERSE TREND FOR THIS DEVICE FAMILY. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO ADVERSE TRENDS FOR THIS DEVICE. BASED ON THE QUALITY INVESTIGATION, THE ADVERSE EVENT WAS REVIEWED AND NO QUALITY RELATED ISSUES WERE IDENTIFIED THAT WOULD WARRANT FURTHER QUALITY INVESTIGATION. ALL DEVICE BATCHES MET IN-PROCESS AND FINAL RELEASE SPECIFICATIONS PRIOR TO DISTRIBUTION. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING FOR SELF FROM (B)(4). THE MEDICAL HISTORY INCLUDED UNSPECIFIED MAJOR SURGERY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING BAND AID BRAND WATER BLOCK CLEAR ADHESIVE BANDAGES CUTANEOUSLY TO PROTECT THE STITCHES FROM A MAJOR SURGERY (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE NOTICED THAT TWO OF HER STITCHES GOT INFECTED AS THE BAND AID DID NOT WORK PROPERLY. SHE STATED THAT SHE WAS LAYING DOWN IN PAIN FROM HAVING TO REDO HER SURGERY TWICE TO GET THE STITCHES PUT BACK AS SHE HAD TO GET THE INFECTION TAKEN CARE OF. THE ACTION TAKEN WITH THE DEVICE AND THE OUTCOME OF EVENT WERE UNKNOWN. THE CONSUMER DID NOT REPORT A SPECIFIC LOT NUMBER; THEREFORE, LOT TRENDING OR FURTHER INVESTIGATION COULD NOT BE PERFORMED. FAMILY TREND ANALYSIS WAS CONDUCTED FOR THIS COMPLAINT. A REVIEW OF THE COMPLAINT DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY DID NOT IDENTIFY AN ADVERSE TREND FOR THIS DEVICE FAMILY. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO ADVERSE TRENDS FOR THIS DEVICE. BASED ON THE QUALITY INVESTIGATION, THE ADVERSE EVENT WAS REVIEWED AND NO QUALITY RELATED ISSUES WERE IDENTIFIED THAT WOULD WARRANT FURTHER QUALITY INVESTIGATION. ALL DEVICE BATCHES MET IN-PROCESS AND FINAL RELEASE SPECIFICATIONS PRIOR TO DISTRIBUTION. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE COMPLAINT SAMPLE WAS NOT RETURNED AS OF (B)(4) 2013. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171742 BAND-AID BRAND WATER BLOCK CLEAR ADHESIVE BANDAGES DRESSING, WOUND, OCCLUSIVE KGX BRAZIL CONSUMER 8137005658 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention