BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAB'S AIR COMPOSITE

    MDR report key: 5159639 · Received October 9, 2015

    Report

    Report Number
    9616062-2015-00001
    Event Type
    Injury
    Date Received
    October 9, 2015
    Report Date
    October 8, 2015
    Manufacturer
    COUSIN BIOTECH S.A.S.
    Product Code
    FTL
    PMA / PMN Number
    K093196
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IT IS ALLEGED THE PATIENT SUFFERED FROM ADHESIONS TO THE BOWELS. ADHESION IS LISTED IN THE IFU AS POSSIBLE ADVERSE REACTIONS. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. COUSIN BIOTECH HAS REQUESTED SEVERAL TIMES ADDITIONAL INFO SUCH AS: PRODUCT REFERENCE, LOT NUMBER, DATE OF CABS'AIR IMPLANTATION, WHAT TYPE OF HERNIA WAS IT; UMBILICAL, INCISIONAL, HOW LONG AFTER CABS'AIR IMPLANTATION DID THE SYMPTOMS OCCUR AND DATE OF CABS'AIR EXPLANTATION, ALL WITHOUT SUCCESS. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. BASED ON THE LIMITED INFO THAT HAS BEEN PROVIDED, AT THIS TIME, NO CONCLUSION CAN BE MADE AS TO THE DEGREE TO WHICH THE MESH IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED PATIENT OUTCOME. FURTHER OUR FDA INSPECTION IN SEPTEMBER, 2015, WE HAVE UPDATED OUR MDR PROCEDURE. BEFORE THIS UPDATE, OUR MDR PROCEDURE DOES NOT REQUIRE TO EVALUATE EVENT THAT OCCURS IN A FOREIGN COUNTRY, ACCORDING TO FDA STANDARD (21 CFR PART 803). REGARDING THIS COMPLAINT, AN ADDITIONAL SURGICAL INTERVENTION HAS BEEN MADE TO SOLVE THE PROBLEM SO THIS COMPLAINT IS REPORTABLE TO FDA.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO COUSIN BIOTECH BY OUR (B)(4) DISTRIBUTOR. THE PATIENT UNDERWENT REPAIR OF A HERNIA W/AN IMPLANT, A COUSIN BIOTECH CABS'AIR COMPOSITE (SURGICAL MESH). AFTER A CERTAIN PERIOD OF TIME, THE PATIENT PRESENTED BOWEL ADHESIONS. THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR THE REMOVAL OF CABS'AIR COMPOSITE MESH. TODAY THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671057 CAB'S AIR COMPOSITE CAB'S AIR COMPOSITE FTL COUSIN BIOTECH S.A.S. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention