BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL+ UD 18IN 4-0 S/A PC-5 PRM MP

    MDR report key: 19398717 · Received May 25, 2024

    Report

    Report Number
    2210968-2024-05588
    Event Type
    Injury
    Date Received
    May 25, 2024
    Date of Event
    December 18, 2023
    Report Date
    May 25, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031055667
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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. 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. TRADE NAME - IRGACARE® ACTIVE INGREDIENT(S) ¿ TRICLOSAN DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL STRENGTH ¿ = 472 G/M H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ¿ WHAT IS THE PROCEDURE NAME? BUNIONECTOMY: CPT ¿ CAPSULE MTTARPHLNGL JT W/WO TENORRHAPHY ¿ WHAT IS THE PROCEDURE DATE? (B)(6) 2023. ¿ WHAT DATE DID THE REACTION OCCUR ON? SUSPECTED (B)(6), 2023, THEN AGAIN ON (B)(6), 20223, CONFIRMED ON (B)(6), 2024 ¿ WHAT DOES THE REACTION LOOK LIKE AND HOW LARGE OF AN AREA DOES THE REACTION COVER? LOOKS LIKE INCISION IS PULLING APART ¿ DO YOU HAVE ANY PICTURES OF THE REACTION? YES ¿ SEE ATTACHED ¿ WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. ANTI-BIOTICS WERE PRESCRIBED AT TIME OF SURGERY AND ENTIRE BOTTLE CONSUMED AS INSTRUCTED. RE-OPERATION WAS CONDUCTED ON (B)(6) 2024 ¿ THIS SURGERY CLEANED OUT THE SCAR TISSUE THAT HAD DEVELOPED INSIDE THE TOE, THE OUTSIDE SCAR, AND A STEEL PIN WAS PLACED INSIDE THE TOE TO HOLD IT STRAIGHT. ¿ WHAT IS THE MOST CURRENT PATIENT STATUS? CONTINUING PHYSICAL THERAPY UNTIL (B)(6) 2024 THEN WILL RE-EVALUATE. ¿ CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED? YES ¿ IT IS VICRYL 5/0, LOT SDMPZU. 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. PLEASE CLARIFY IF ALL 3 SUTURES USED WERE ALL RELATED TO THIS EVENT. -VCP500G/ LOT SDMPZU QUANTITY (B)(4) -VCP232H/ SL2BEO (INVALID LOT #) QUANTITY (B)(4). -VCP823G (LOT UNKNOWN) QUANTITY (B)(4) OR WAS ONLY VICRYL 5/0, VCP500G/ LOT SDMPZU RELATED TO THIS EVENT? IF YES, WHAT IS THE QUANTITY THAT CONTRIBUTED TO THIS EVENT? SL2BEO IS AN INVALID LOT NUMBER. PLEASE PROVIDE A VALID LOT # FOR VCP232H. DID THE PATIENT EXPERIENCE A WOUND DEHISCENCE? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, 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 TISSUE DEHISCED? PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. DID THE SUTURE UNTIE, BREAK, OR PULL OUT OF THE TISSUE? WERE THERE ANY PATIENT STRESS FACTORS THAT LED TO THE SUTURE UNTYING, BREAKING OR PULLING OUT OF THE TISSUE? ONSET DATE/TIME OF DEHISCENCE? (# POST OP DAYS) HOW WAS THE DEHISCENCE MANAGED? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? 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? IF APPLICABLE, WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. SURGEON¿S NAME? INVESTIGATION SUMMARY THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW THREE OPEN ALUMINUM PACKS, AND THE PATIENT'S SCARRING IS ALSO SHOWN IN TWO OTHER IMAGES. THE IMAGE IS NOT CLEAR TO DETERMINE THE FAILURE MODE. BASED ON THE PHOTO REVIEW, NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BUNIONECTOMY: CPT ¿ CAPSULE METAPHALANGEAL JT W/WO TENORRHAPHY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT EXPERIENCED A POST OP REACTION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657133 VCL+ UD 18IN 4-0 S/A PC-5 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. 10705031055667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention