BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL* UND 3-0 70CM (1)SC-20

    MDR report key: 10565746 · Received September 22, 2020

    Report

    Report Number
    2210968-2020-07188
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    June 18, 2020
    Report Date
    September 2, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 12/4/2020. ADDITIONAL INFORMATION: H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AM7112, AND NO NON CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 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 Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 12/3/2020. ADDITIONAL INFORMATION: A1, A2, A4. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: (B)(4) REFER TO THE SAME EVENT ¿ PATIENT ECRR: IMPACTED PRODUCTS INVOLVED IN THE SAME EVENT: MONOCRYL 4/0 PS-2: PMZ621. VICRYL 3/0 SC-20: AM7112. NOTE: EVENT RELATED TO THIS PATIENT FOR LOT AM7112, J123H WILL BE REPORTED UNDER MW # 2210968-2020-09111; INFORMATION RELATED TO LOT PMZ621, MCP426H WILL BE REPORTED UNDER 2210968-2020-07189. (B)(4). DATE SENT TO THE FDA: 12/3/2020. CORRECTED INFORMATION: B1, B2, H1 ¿ IT WAS REPORTED THAT THIS MW REPORT # 2210968-2020-07188 IS A DUPLICATE OF MW # 2210968-2020-09111. THEREFORE ALL INFORMATION REGARDING THIS EVENT WILL BE CAPTURED UNDER MW #2210968-2020-09111.

    Additional Manufacturer Narrative · 1

    (B)(4). HOSPITALIZATION FOR FURTHER DIAGNOSIS 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 CLARIFY 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. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? IN WHAT TISSUE WAS THE SUTURE PLACED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? HOW WAS THE SUTURE PLACED, INTERRUPTED OR CONTINUOUS? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? WHAT WAS THE ONSET DATE OF SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? WHAT TISSUE DEHISCED? HOW WAS THE DEHISCENCE MANAGED? IF A SURGICAL INTERVENTION WAS PERFORMED, PROVIDE DATE AND APPEARANCE OF SUTURE DURING THE PROCEDURE. DID THE PATIENT EXPERIENCE AN INFECTION? IF YES, WERE CULTURES PERFORMED? RESULTS? PLEASE CLARIFY WHAT IS MEANT BY ¿TAKES CROP¿. WERE THERE CHANGES TO PRE-OP CLEANSERS OR PROCEDURES? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? OTHER RELEVANT PATIENT HISTORY / CONCOMITANT MEDICATIONS. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT MODIFIED RADICAL MASTECTOMY SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT DUE TO COMPLETE DEHISCENCE OF THE SURGICAL WOUND, WITH DISCHARGE OF FETID PURULENT MATERIAL. IT WAS REPORTED THE PATIENT STARTS AB, TAKES CROP. VAC SYSTEM WAS IMPLEMENTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030106 VICRYL* UND 3-0 70CM (1)SC-20 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AM7112

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization