BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN - MAXON

    MDR report key: 15547125 · Received October 5, 2022

    Report

    Report Number
    9612501-2022-01708
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    April 13, 2022
    Report Date
    October 5, 2022
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: UNKNOWN-VLOC, UNKNOWN VLOC, PRODUCT LOT # UNK. TITLE: DUODENAL SWITCH COMBINED WITH SYSTEMATIC POST-OPERATIVE SUPPLEMENTATION AND REGULAR PATIENT FOLLOW-UP RESULTS IN GOOD NUTRITIONAL OUTCOMES SOURCE: OBESITY SURGERY (2022) 32:2226¿2236 HTTPS://DOI.ORG/10.1007/S11695-022-06063-3. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED MAY 2008 AND MAY 2015 REGARDING A RETROSPECTIVE THAT STUDY THE EVALUATED THE OUTCOMES OF PATIENTS THAT UNDERWENT DUODENAL SWITCH SURGERY FOR WEIGHT LOSS ON 65 PATIENTS. THE ALIMENTARY LIMB WAS ELEVATED IN AN ANTECOLIC FASHION AND AN END TO SIDE ANASTOMOSIS WAS PERFORMED WITH THE PROXIMAL DUODENUM USING CONTINUOUS SUTURE. THE MESENTERIC DEFECTS AT THE JEJUNOJEJUNOSTOMY AND BETWEEN THE ILEAL MESENTERY AND TRANSVERSE MESOCOLON WERE ROUTINELY CLOSED WITH THE NON-ABSORBABLE SUTURE. THERE WERE POSTOPERATIVE COMPLICATIONS INCLUDED: INTRA-ABDOMINAL COLLECTIONS, ANASTOMOTIC BLEEDING, AND AN ANASTOMOTIC LEAK, WITH FIVE PATIENTS REQUIRED REOPERATION TO RESOLVE THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045785 UNKNOWN - MAXON SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM DAVIS & GECK CARIBE LTD UNKNOWN - MAXON

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention