BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 10538798 · Received September 15, 2020

    Report

    Report Number
    9614546-2020-00414
    Event Type
    Injury
    Date Received
    September 15, 2020
    Report Date
    September 15, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. MODEL NUMBER: MODEL NUMBER UNKNOWN. SERIAL NUMBER: UNKNOWN/NOT PROVIDED. CATALOG#: CATALOG NUMBER UNKNOWN. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ADDITIONAL INFORMATION: DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: THE COMPLAINT HISTORY WAS NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A QUALITY PRODUCT DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. PAEDIATRIC ENDOPHTHALMITIS: 'A UK RETROSPECTIVE STUDY'. HTTPS://DOI.ORG/10.1038/S41433-019-0546-4, PUBLISHED ONLINE: 12 AUGUST 2019 © THE AUTHOR(S), UNDER EXCLUSIVE LICENSE TO THE ROYAL COLLEGE OF OPHTHALMOLOGISTS 2019. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: 'PAEDIATRIC ENDOPHTHALMITIS: A UK RETROSPECTIVE STUDY'. A RETROSPECTIVE STUDY WAS DONE TO DETERMINE THE INCIDENCE AND RISK FACTORS OF EXOGENOUS ENDOPHTHALMITIS IN CHILDREN, AND TO DEVELOP AN EVIDENCE-BASED PROTOCOL THAT CAN BE USED FOR TREATMENT OF SUSPECTED EXOGENOUS ENDOPHTHALMITIS IN CHILDREN. THREE PATIENTS ON BAERVELDT IMPLANT REPORTED IN THE STUDY DEVELOPED POSTOPERATIVE ENDOPHTHALMITIS, TWO OF WHICH HAD NO ASSOCIATED MICRO-ORGANISM GROWTH (N=2), AND ONE WAS ASSOCIATED WITH STREPTOCOCCUS PYOGENES (N=1). SECONDARY TO POSTOPERATIVE ENDOPHTHALMITIS, ONE OF THE THREE PATIENTS HAD NO PERCEPTION OF LIGHT PTHISIS (N=1), AND ONE PATIENT ONLY HAD VISUAL ACUITY OF HAND MOVEMENTS (N=1). INTERVENTION INCLUDED INTRAVITREAL, INTRAVENOUS AND TOPICAL ANTIBIOTICS. GLAUCOMA DRAINAGE IMPLANTS WERE REMOVED IN EIGHT CASES WITH BAERVELDT IMPLANT IN SITU OR THE OTHER PRODUCT AT THE TIME OF ACUTE TREATMENT FOR ENDOPHTHALMITIS. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003421 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention