BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 22536109 · Received July 17, 2025

    Report

    Report Number
    2210968-2025-08305
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    November 12, 2020
    Report Date
    September 30, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WE HAVE THE CONTACTS AND PATIENT AUTHORIZATION TO CONTACT THE SURGEON.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(6). 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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. 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. ARE ANY DEVICES BEING RETURNED? IF YES, PLEASE PROVIDE TRACKING INFORMATION. PATIENT: 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 THE FOLLOWING INFORMATION ON THE AUTHORIZATION TO USE OR DISCLOSE INFORMATION FORM ATTACHED: YOUR SURGEON¿S NAME, EMAIL, PHONE NUMBER, ADDRESS YOUR SIGNATURE. PLEASE SCAN THE SIGNED FORM AND EMAIL BACK TO ETHICON.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INFORMATION: H6.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A PATIENT THAT THEY UNDERWENT A BILATERAL REDUCTION MASTOPLASTIES ON (B)(6) 2020 AND SUTURE WAS USED. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2020. THE PATIENT WAS BEING TREATED FOR HYPERTROPHY WITH BILATERAL BREAST PTOSIS WITH PHYSICAL DISCOMFORT AND PSYCHIC REPERCUSSIONS. PROCEDURE INFORMATION: GENERAL ANESTHESIA WITH ORE-TRACHEAL INTUBATION, HALF SITTING POSITION, BETADINE ANTISEPSIS ACCORDING TO PROTOCOL AFTER DEBRIDEMENT, ANTIBIOTIC PROPHYLAXIS ACCORDING TO PROTOCOL, CHAMPAGNE, VERIFICATION OF PREOPERATIVE DRAWING, START WITH THE RIGHT SIDE. PERIAREOLAR DESEPIDERMISATION ON A RAISED MAMMOSTAT OF THE NIPPLE FLAP WITH SUPERIOR PEDICLE RESECTION OF A CENTRAL PART IN A KEEL OF A BOAT ADAPTATION OF LATERAL PILLARS TO DEMAND. RIGHT RESECTION PIECE: 760 G, HEMOSTASIS, SUTURE OF THE PILLARS WITH VICRYL 1, INSTALLATION OF THE AREOLA WHICH IS SUTURED BY SKOOG STITCHES WITH RAPID VICRYL 4.0. SUTURE OF THE VERTICAL WITH INVERTING POINTS OF MONOCRYL 4/0 AND AN INTRADERMAL OVERJET OF MONOCRYL 4/0. SUTURE OF THE HORIZONTAL OF INVERTING POINTS OF MONOCRYL 3/0 AND AN INTRADERMAL OVERJET OF MONOCRYL 3/0. REALIZATION OF A SIMILAR SURGICAL TECHNIQUE ON THE LEFT SIDE. WEIGHT OF THE RESECTION PIECE: 762 G, FINAL SYMMETRY CONTROL, STÉRISTRIPS, SPO: ANTALIGUES, ANTI-EMETIC, J1 OR J2 OUTPUT DEPENDING ON GENERAL STATUS, WEARING THE COMPRESSION BRA PERMANENTLY FOR 1 MONTHS, THE PATIENT WAS DISCHARGED ON (B)(6) 2020. THE PATIENT REPORTED THAT AFTER HER SURGERY, SHE HAD ADVERSE REACTIONS, SUSPECTED TO BE DUE TO AN ALLERGY TO THE SUTURES USED. FOUR YEARS LATER, THE PATIENT STILL FELT PERSISTENT PAIN IN HER RIGHT SIDE. THE PATIENT REPORTED A LOT OF DIFFICULTY WEARING BRAS, AS IT HURTS HER SCARS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671087 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other