BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12618977 · Received October 12, 2021

    Report

    Report Number
    2210968-2021-09570
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    August 12, 2020
    Report Date
    October 12, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: AM J OPHTHALMOL 2021;221:75¿82. HTTPS://DOI.ORG/10.1016/J.AJO.2020.08.026.

    Description of Event or Problem · 0

    TITLE: INCIDENCE AND OUTCOMES OF HYPERTENSIVE PHASE FOLLOWING AUROLAB AQUEOUS DRAINAGE IMPLANT SURGERY IN ADULTS WITH REFRACTORY GLAUCOMA THE AIM OF THIS RETROSPECTIVE, NONCOMPARATIVE, INTERVENTIONAL CASE SERIES IS TO REPORT THE INCIDENCE AND OUTCOMES OF HYPERTENSIVE PHASE (HP) FOLLOWING AUROLAB AQUEOUS DRAINAGE IMPLANT (AADI) (AUROLAB) SURGERY IN ADULTS WITH REFRACTORY GLAUCOMA. A TOTAL OF 200 EYES (69 WERE MALE) WHO UNDERWENT AUROLAB AQUEOUS HUMOR DRAINAGE IMPLANT (AADI; AUROLAB, MADURAI, INDIA) IMPLANTATION WERE INCLUDED IN THE STUDY. A 6-0 POLYGLACTIN SUTURES (BRAIDED COATED POLYGLACTIN 910 VIOLET; ETHICON, JOHNSON & JOHNSON LTD, MUMBAI, INDIA) WAS USED IN LIGATING THE TUBE AT THE TUBE-PLATE JUNCTION. REPORTED COMPLICATION INCLUDES SEVERE ANTERIOR UVEITIS (N=5). IN CONCLUSION, A THIRD OF EYES THAT UNDERWENT AADI PLACEMENT EXPERIENCED HP. HP WAS SUCCESSFULLY MANAGED WITH ADDITIONAL IOP-LOWERING MEDICATIONS IN A MAJORITY OF CASES AND DID NOT HAVE A SIGNIFICANT INFLUENCE ON LONG-TERM SUCCESS RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511508 POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1