BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE UNKNOWN

    MDR report key: 12307967 · Received August 11, 2021

    Report

    Report Number
    2210968-2021-07237
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    January 1, 2021
    Report Date
    July 20, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 09/09/2021. 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: I DID A SUTURE REACTIVITY TEST LAST MONTH WITH A SINGLE INTERRUPTED SUTURE AND SHOWED NO REACTION TO VYCRIL, BUT SHOWED SIGNS OF REACTION TO NYLON SUTURES THAT WERE ALSO USED AT THE INITIAL SURGERY. THE SUTURES USED WERE ETHYLON NYLON 3.0. REACTION STARTED BETWEEN 5 AND 6 DAYS POST OPERATIVELY. AT THIS TIME I WOULD WITHDRAW THE COMPLAINT ON VYCRIL AND RESUBMIT AS NYLON (FROM SAME COMPANY). THIS IS LIKELY AN ALLERGIC REACTION TO NYLON SUTURES IN GENERAL AND NOT YOUR PRODUCT IN PARTICULAR. PS: I HAD A VAGUE CHILDHOOD HISTORY OF NYLON CLOTHING DERMATITIS (B)(4). DATE SENT TO FDA: 09/09/2021.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CAN YOU PLEASE PROVIDE THE NAME AND DATE OF THE PROCEDURE IN WHICH VICRYL SUTURE WAS USED? HOW LONG AFTER THE PROCEDURE WAS THE SUSPECTED ALLERGIC REACTION FIRST NOTED? WHAT KIND OF SYMPTOMS ARE YOU EXPERIENCING? WAS ANY MEDICATION PROVIDED FOR THE SUSPECTED ALLERGIC REACTION? IF SO, CAN YOU PROVIDE THE MEDICATION NAME AND RESULTS? DID YOU UNDERGO ANY SURGICAL INTERVENTION AS A RESULT OF THE SUSPECTED ALLERGIC REACTION? IF SO, CAN YOU PROVIDE THE DATE? HAVE YOU SEEN A PHYSICIAN OR SURGEON ABOUT THIS ISSUE? IF YES, WHAT DID THEY SAY ABOUT YOUR CONDITION? IF IN YOUR POSSESSION, MAY WE HAVE A COPY OF YOUR OPERATIVE REPORT? DOES ETHICON HAVE YOUR PERMISSION TO CONTACT YOUR SURGEON, IN THE EVENT ETHICON WOULD LIKE TO CONTACT YOUR SURGEON FOR MORE CLINICAL INFORMATION TO BE USED FOR A PRODUCT QUALITY COMPLAINT INVESTIGATION? IF SO, PLEASE PROVIDE YOUR SURGEONS NAME, CONTACT INFORMATION, AND SIGN RELEASE OF MEDICAL INFORMATION FORM ATTACHED. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4). THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT MW5102134.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE PATIENT REPORTED EXPERIENCING A SUSPECTED ALLERGIC REACTION TO THE SUTURE LEADING TO SEVERE CONTACT DERMATITIS WHICH REQUIRED UNSPECIFIED HOSPITALIZATION AND/OR INTERVENTION. THE PATIENT IS CURRENTLY UNDERGOING ALLERGY TESTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207092 SUTURE UNKNOWN SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention