BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL+ UD 27IN 4-0 S/A FS-2

    MDR report key: 11139152 · Received January 8, 2021

    Report

    Report Number
    2210968-2021-00157
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    December 2, 2020
    Report Date
    April 13, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031053090
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 02/04/2021 ADDITIONAL INFORMATION: E2115 ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING THE SUTURE PLACEMENT AND/OR DURING DEBRIDEMENT PROCEDURES? - NOT MENTION WHAT TYPE OF DEBRIDEMENT WAS PERFORMED? WAS IT REQUIRED ANESTHESIA ADDITIONALLY? PLEASE SPECIFY. - WOUND INFECTION TO FORM A PUS CAVITY, THE FIRST INCISION OF THE PUS CAVITY TO REMOVE PUS, CUT OFF VISIBLE SUTURE; THE WOUND WAS RE-EXPOSED FOR A SECOND TIME AND DRAINED OTHER RELEVANT PATIENT FACTORS/COMORBIDITIES/CONCOMITANT MEDICATIONS? - NO WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT (ABSCESS AND POOR WOUND HEALING)?- ABSORPTION OF SUTURE FOR TOO LONG AND MATERNAL PHYSICAL FITNESS RELATED TO THE FORMATION OF INFECTION WHAT IS THE PATIENT¿S CURRENT STATUS? -DISCHARGED FROM HOSPITAL THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: THE PATIENT DEMOGRAPHIC INFO: WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? LOT 1180049 IS INVALID. PLEASE CLARIFY A PRODUCT NAME, CODE AND/OR LOT NUMBER? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WAS ANY PRESCRIBED MEDICATION REQUIRED FOR TREATMENT? PLEASE SPECIFY. WERE CULTURES PERFORMED? RESULTS? 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. DATE SENT TO THE FDA: 02/04/2021 CORRECTED H6. MEDICAL DEVICE PROBLEM CODE: A04 CORRECTED INFORMATION: D2A, D2B 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: 4/13/2022. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. 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 INFORMATION WAS PROVIDED: THE PRODUCT CODE INVOLVED ARE VCP422H AND VCP917H(BOTH LOT NUMBER ARE UNKNOWN). NOTE: EVENTS REPORTED IN 2210968-2022-02645. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 275 G/M PC-000827754. DATE SENT TO THE FDA: 4/13/2022. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. 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. CORRECTED INFORMATION; D1, D2A, D2B, D3, D4, G4. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 275 ¿G/M.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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: WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? LOT 1180049 IS INVALID. PLEASE CLARIFY A PRODUCT NAME, CODE AND/OR LOT NUMBER? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING THE SUTURE PLACEMENT AND/OR DURING DEBRIDEMENT PROCEDURES? WERE CULTURES PERFORMED? RESULTS? WHAT TYPE OF DEBRIDEMENT WAS PERFORMED? WAS IT REQUIRED ANESTHESIA ADDITIONALLY? PLEASE SPECIFY. WAS ANY PRESCRIBED MEDICATION REQUIRED FOR TREATMENT? PLEASE SPECIFY. OTHER RELEVANT PATIENT FACTORS/COMORBIDITIES/CONCOMITANT MEDICATIONS? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT (ABSCESS AND POOR WOUND HEALING)? WHAT IS THE PATIENT¿S CURRENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DELIVERED SPONTANEOUSLY ON (B)(6) 2020 AND THE UNKNOWN SUTURE WAS USED TO SUTURE TORN RIGHT LABIA MAJORA. THE PATIENT EXPERIENCED POOR WOUND HEALING. ONE MONTH LATER, ABOUT 1.5 CM ABSCESS APPEARED AT THE SUTURE SITE, AND MULTIPLE DEBRIDEMENT WAS PERFORMED; REPEATED ONE WEEK LATER AND TWO WEEKS LATER, AND WOUND HAS NOT HEALED YET. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36420 VCL+ UD 27IN 4-0 S/A FS-2 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP422H 10705031053090
    36424 VCL+ UD 27IN 4-0 S/A FS-2 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP422H 10705031053090
    36425 VCL+ UD 27IN 4-0 S/A FS-2 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP422H 10705031053090

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention