BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 16824477 · Received April 27, 2023

    Report

    Report Number
    2210968-2023-03057
    Event Type
    Injury
    Date Received
    April 27, 2023
    Report Date
    May 5, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WERE THERE ANY ALLEGED DEFICIENCIES NOTED WITH THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PATIENT¿S POST-OPERATIVE COMPLICATIONS AS MENTIONED IN THE EVENT DESCRIPTION? FIRST, I AM NOT ¿ALLEGING¿, I AM SIMPLY ATTEMPTING TO FIND INFORMATION ABOUT TESTING FOR ALLERGIES. MYSELF AND THE SURGEON WOULD BE INCREDIBLY INTELLIGENT IF THAT QUESTION COULD BE ANSWERED HONESTLY AFTER 20 + YEARS. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. ONCE THE INCISION DEHISCENCE OCCURRED THE SUTURES WERE REMOVED AS THEY SURFACED TO THE TOP, (WITH BOTH THE VICRYL & THE MONOCRYL). THE INCISION THEN HEALED ON ITS OWN FROM THE INSIDE OUT, NO RECLOSURE. THERE WAS A PRESCRIPTION FOR STEROIDS OR ANTIBIOTICS FOR THE PATIENT'S RECOVERY? IF YES, PLEASE PROVIDE MEDICATION NAME, ROUTE AND DOSE. I DONT BELIEVE THAT I TOOK STEROIDS, ALTHOUGH AGAIN, 20 + YEARS AGO! THE POSSIBILITY/PROBABILITY OF ANTIBIOTICS SEEMS TO BE REASONABLE. WAS DEHISCENCE NOTED. YES, THE FIRST SURGERY WAS LEFT TO HEAL ON ITS OWN. THE SECOND SURGERY THE WOUND WAS PACKED TWICE A DAY (AS I WORKED WITH A WOUND CARE NURSE). BOTH CLOSURES TOOK APPROXIMATELY 3 MONTHS TO COMPLETELY HEAL. WHAT IS THE LOT NUMBER & PRODUCT CODE? AGAIN, 20 + YEARS AGO! IMPOSSIBLE QUESTION. THE THIRD SURGERY, AGAIN APPROXIMATELY ONE YEAR AFTER THE SECOND THE SURGEON DID NOT USE ANY ABSORBABLE SUTURES. AFTER 3 YEARS OF CRUTCHES, BOOTS, CASTS¿.. I WAS FINALLY HEALED ALBEIT PERMANENTLY NUMB ON THE BOTTOM OF MY LEFT FOOT AND A TREMENDOUS AMOUNT OF TIME IN PHYSICAL THERAPY. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DID YOU EXPERIENCE A SUTURE REACTION AFTER YOUR 3RD SURGERY? NO THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: WHAT TYPE OF SURGERY DID YOU HAVE OVER 20 YEARS AGO? WHAT WAS THE REASON FOR THIS SURGICAL PROCEDURE? PLEASE PROVIDE THE DATE OF SURGERY, IF KNOWN. HAVE YOU HAD ANY ALLERGY TESTING PERFORMED? IF YES, WHAT WERE THE RESULTS? DO YOU KNOW IF THIS EVENT WAS REPORTED TO ETHICON PREVIOUSLY? (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. WHAT TYPE OF SURGERY DID YOU HAVE OVER 20 YEARS AGO? WHAT WAS THE REASON FOR THIS SURGICAL PROCEDURE? PLEASE PROVIDE THE DATE OF SURGERY, IF KNOWN. HAVE YOU HAD ANY ALLERGY TESTING PERFORMED? IF YES, WHAT WERE THE RESULTS? DO YOU KNOW IF THIS EVENT WAS REPORTED TO ETHICON PREVIOUSLY? NOTE: RELATED EVENTS REPORTED VIA 2210968-2023-03056.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT AN UNKNOWN PROCEDURE OVER TWENTY YEARS AGO AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A REACTION TO THE SUTURE. THE PATIENT EXPERIENCED A DEHISCENCE OF THE INCISION AND SPITTING OF THE SUTURE. THE PATIENT HAD TO GO TO A WOUND CARE SPECIALIST AND HAD TO HAVE THE WOUND PACKED AND HEAL FROM THE INSIDE OUT AS THEY WERE UNABLE TO CLOSE THE WOUND AGAIN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559508 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other