BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS VIO 8X45CM M2::USP3/0 SGLE ARMED SH C/R

    MDR report key: 12858133 · Received November 22, 2021

    Report

    Report Number
    2210968-2021-11905
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    September 1, 2021
    Report Date
    February 9, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    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

    (B)(4). DATE SENT TO THE FDA: 2/9/2022. 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 REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS MEANT BY ¿THE OPERATOR REPORTED THAT THE INTRAOPERATIVE SUTURE WAS SMOOTH¿? AFTER CONFIRMATION, IT WAS A TYPING ERROR, "SMOOTH "HERE MEANS THE OPERATION WENT WELL. WAS THERE A PROBLEM WITH THE BARBS ON THE STRATAFIX SUTURE? IF YES, WAS THIS ISSUE RELATED TO THE INFECTION? PLEASE EXPLAIN. NO OBVIOUS PROBLEM OBSERVED ON BARBS. IT'S NOT CLEAR WHAT CAUSED THE INFECTION, WHICH NEEDS TO BE INVESTIGATED WAS THE ¿SMOOTH¿ SUTURE USED ANYWAY? NO, NO PROBLEM WAS REPORTED ON THE APPEARANCE OF SUTURE. THE BARB IS ON THE SUTURE. DID THE BARBS HOLD IN THE TISSUE? YES.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 REQUESTED AND THE FOLLOWING WAS OBTAINED: AFTER INVESTIGATION, THE PATIENT (MALE, SPECIFIC AGE UNKNOWN) UNDERWENT REMOVAL OF INTERNAL FIXATION DEVICE FOR RIGHT ACROMIOCLAVICULAR JOINT FRACTURE IN (B)(6) HOSPITAL ON (B)(6) 2021. THE OPERATOR USED ABSORBABLE SUTURE MANUFACTURED BY OUR COMPANY (SXPP1A405) FOR SUBCUTANEOUS TISSUE SUTURE IN A CONTINUOUS SUTURE MANNER (THE SKIN TISSUE SUTURE METHOD AND THE PRODUCT USED WERE UNKNOWN) DURING SURGERY. THE OPERATOR REPORTED THAT THE INTRAOPERATIVE SUTURE WAS SMOOTH.THE PATIENT HAD INCISION SWELLING AND EXUDATION WITHOUT OBVIOUS INDUCEMENT AFTER THE OPERATION (THE SPECIFIC EVENT OCCURRED ON AN UNKNOWN DATE). AFTER EXAMINATION, THE DOCTOR GAVE THE INCISION DRESSING CHANGE AND OTHER SYMPTOMATIC TREATMENT (THE SPECIFIC TREATMENT METHOD WAS UNKNOWN). THE SYMPTOMS WERE NOT SIGNIFICANTLY IMPROVED. ON (B)(6) , THE PATIENT'S SURGICAL INCISION INFECTION SYMPTOMS WERE AGGRAVATED, ACCOMPANIED BY SUTURE DISCHARGE AND INCISION SECRETION AT THE INCISION SUTURE. THE DOCTOR CONSIDERED THE PATIENT'S INCISION INFECTION, AND CUT OFF THE INCISION SUTURE TO DISCHARGE THE SUTURE. THE INCISION WAS DEBRIDED AND DISINFECTED AND TREATED WITH ANTIBIOTICS (THE DRUG NAME, DOSE, FREQUENCY, CYCLE AND OTHER SPECIFIC MEDICATION INFORMATION WERE UNKNOWN). THEN THE INCISION INFECTION WAS NOT IMPROVED. THEREFORE, ON (B)(6) 2021, THE NON-ABSORBABLE SUTURE WAS REMOVED FROM THE SUBCUTANEOUS TISSUE OF THE INCISION AND REPLACED WITH A NEW SUTURE (THE SPECIFIC PRODUCT NAME AND MODEL WERE UNKNOWN) FOR SECONDARY SUTURE. THE DOCTOR CULTURED THE RESIDUAL ABSORBABLE SUTURE IN THE REMOVED PATIENT'S BODY FOR BACTERIAL CULTURE. THE CULTURE RESULTS SHOWED THAT THE BACTERIA WERE RELATED TO THE ABSORBABLE SURGICAL SUTURE. THE HOSPITAL FEEDBACK CONSIDERED THAT THE BACTERIA WERE RELATED TO THE ABSORBABLE SURGICAL SUTURE.THE PATIENT WAS IN A STABLE CONDITION AND NO FURTHER ADVERSE EVENTS WERE REPORTED.ACCORDING TO THE EVENT INFORMATION OBTAINED CURRENTLY, THE PATIENT SHOWED INCISION SWELLING AND EXUDATION WITHOUT OBVIOUS INDUCEMENT AFTER THE SURGERY (THE SPECIFIC EVENT OCCURRED ON AN UNKNOWN DATE), THIS IS ESTIMATED AS (B)(6) 2021, AND IT IS INDICATED. IF IN YOUR POSSESSION, MAY WE HAVE A COPY OF YOUR OPERATIVE REPORT? : WE DON¿T HAVE ANY 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 SURGEON¿S NAME, CONTACT INFORMATION AND SIGN RELEASE OF MEDICAL INFORMATION FORM ATTACHED. : NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    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. COMPONENT CODE: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER MD2641/VCP774ZCC31 AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. SUMMARY: AFTER VISUAL INSPECTION OF THE IMAGES RECEIVED TO ETHICON INC FOR EVALUATION. A WOUND WITH INFLAMMATION WAS OBSERVED. NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED COMPLAINT, AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. 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. 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 SURGEON¿S NAME, CONTACT INFORMATION. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH = 275 G/M. EVENTS WERE SUBMITTED VIA 2210968-2021-11903.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF THE FRACTURE INTERNAL FIXATION DEVICE ON RIGHT ACROMIOCLAVICULAR JOINT ON (B)(6) 2021 AND THE SUTURE WAS USED. THE PATIENT EXPERIENCED POST-OP INFECTION ACCOMPANIED BY EXUDATION OF PUS AND THE SUTURE OUT OF THE SKIN. IT WAS REPORTED ALSO THAT ON (B)(6) 2021, IT REMOVED THE SUTURE OUT OF THE SKIN INFECTION AGGRAVATED. THE SECOND SURGERY ON (B)(6) 2021 WAS HANDLED BY A PROFESSIONAL PHYSICIAN AND THE RESIDUAL SUTURE WAS CULTURED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754534 VICRYL PLUS VIO 8X45CM M2::USP3/0 SGLE ARMED SH C/R SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. MD2641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention