BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL+ VIO 36IN 2-0 S/A CT-1

    MDR report key: 12519196 · Received September 23, 2021

    Report

    Report Number
    2210968-2021-08791
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    September 2, 2021
    Report Date
    September 13, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031052550
    PMA / PMN Number
    K132580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 10/07/2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE RC2APC/VCP345HCN31 AND NO NON CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? 29 YEARS OLD, FEMALE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE (B)(6) 2021? 41 WEEKS OF PREGNANCY, SINGLE LIVE FETUS TO BE DELIVERED. WERE ANY CONCOMITANT PROCEDURES PERFORMED? - NO. ON WHAT TISSUE WAS THE SUTURE USED? - SUBCUTANEOUS TISSUE, SKIN. WHAT IS THE PATIENT'S CURRENT STATUS?- DISCHARGE SMOOTHLY. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE ANY PRE-OP CLEANSING PROCEDURES OR PRODUCTS CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? PLEASE SPECIFY. HOW MUCH AND WHAT TYPE OF PUS IS PRESENT IN THIS WOUND? WERE ANY CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTIONS PERFORMED TO TREAT SYMPTOMS INCLUDING MEDICATION NAME AND RESULTS. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 · 1

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (B)(4) ¿ DEVICE NOT RETURNED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO RECEIVE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE (B)(6) 2021? WERE ANY CONCOMITANT PROCEDURES PERFORMED? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE ANY PRE-OP CLEANSING PROCEDURES OR PRODUCTS CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? PLEASE SPECIFY. HOW MUCH AND WHAT TYPE OF PUS IS PRESENT IN THIS WOUND? WERE ANY CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTIONS PERFORMED TO TREAT SYMPTOMS INCLUDING MEDICATION NAME AND RESULTS. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, STRENGTH = 275 G/M.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LATERAL PERINEOTOMY DURING UNKNOWN SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. ON (B)(6) 2021, THE SURGICAL SITE WAS FOUND TO HAVE PUS. THE PATIENT EXPERIENCED POST-OP WOUND HEALING DELAY. SUBSEQUENT DISPOSITION IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418249 VCL+ VIO 36IN 2-0 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP345H RC2APC 10705031052550

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR