BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 4113254 · Received September 24, 2014

    Report

    Report Number
    2210968-2014-13649
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    December 14, 2013
    Report Date
    September 4, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT RIGHT FOOT SCARF OSTEOTOMY ON (B)(6) 2013. ON (B)(6) 2014 UPON FOLLOW UP WITH PHYSICIAN, THE PATIENT WAS FOUND TO HAVE DEHISCENCE WITH YELLOW STRAW COLORED DISCHARGE AND SOME SLOUGH, MODERATE PERI-WOUND ERYTHEMA AND SWELLING THAT WAS TENDER. THE WOUND WAS DEBRIDED AND THE PATIENT WAS ADMINISTERED FLUCLOXACILLIN 500 MG QDS. THE PATIENT WAS DIAGNOSED WITH DEEP POST OPERATIVE WOUND INFECTION AND PATIENT CONTINUED WITH WEEKLY PODIATRY VISITS AND DEBRIDEMENT. THE SURGEON OPINED THAT PATIENT EXPERIENCED REACTION TO SUTURE. ON (B)(6) 2014, UPON FOLLOW UP, THE PATIENT¿S RIGHT HALLUX VALGUS SKIN INCISION WAS HEALED WITH SOME SCAR SENSITIVITY TO PALPATION. ON (B)(6) 2014, UPON FOLLOW UP WITH THE PHYSICIAN, THE PATIENT REPORTED FEELING BETTER, SKIN INCISION WAS WELL HEALED AND THE SCAR WAS MINIMALLY TENDER TO PALPATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT, SINCE THE PROCEDURE, THE PATIENT EXPERIENCED SLEEPLESS NIGHT, EXHAUSTION, UPSET AND DEPRESSION. THE PHYSICIAN ADVISED THE PATIENT TO BE OFF WORK FOR 6-8 WEEKS AFTER THE PROCEDURE BUT THE PATIENT WAS IN FACT OFF MUCH LONGER THAN THIS DUE TO THE PROBLEM THAT OCCURRED. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BUNION REMOVAL FOOT SURGERY ON (B)(6) 2013 AND SUTURE WAS USED. THE PATIENT DEVELOPED PAIN 72 HRS LATER. THE SUTURES WERE REMOVED ON (B)(6) 2013. THE PATIENT REMAINS IN PAIN. THE WOUND SPLIT OPEN ON (B)(6) 2014. ON (B)(6) 2014, ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS TAKING IBUPROFEN AND PARACETOMOL. THE PATIENT HAS BEEN IN PHYSIO SINCE (B)(6) 2014. THE PATIENT HAS HAD HER FOOT LANCED AND HAS HAD 11 CONSULTATIONS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593235 VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK DC5GDXP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention