BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL RAP UND 45CM M0.7 USP6/0 SGLE ARMED P-1 PRIME

    MDR report key: 22836261 · Received August 18, 2025

    Report

    Report Number
    2210968-2025-09465
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 26, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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: 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?- 46-YEAR-OLD MALE WEIGHT: 57KG LENGTH: 1.71M LEFT LOWER EYELID PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL INFECTION). PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE. - INITIAL SURGERY: 25/06/2025 (WOUND RE-SUTURED IN ROOMS 30.07.2025) WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE?- NONE IF YES, PLEASE DESCRIBE ARE THERE ANY PHOTOS AVAILABLE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? - YES, PHOTOS ARE AVAILABLE NO CO-MORBIDITIES WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? - NORMAL DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? - YES. TOPICAL TOBRAMYCIN TDS. ORAL CLINDAMYCIN BD WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? - DR. LENAKE IS CONCERNED THAT IT MIGHT BE THE VICRYL 6/0 RAPID USED ON THE PATIENT. VICRYL 6/0 WAS ALSO USED ON THE PATIENT PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. - (WOUND RE-SUTURED IN ROOMS 30.07.2025). WERE CULTURES PERFORMED?- NO WHAT IS THE PATIENT'S CURRENT STATUS?- HEALTHY. WOUND HEALED POST RE-SUTURING. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? - NO. IF SO, PLEASE PROVIDE THE RESULTS. HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? - NO DRAINAGE. WOUND DEHISCED AND SLOUGHY. PRE-OP CLEANSING WITH BETADINE (AS ALWAYS). WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. - NO, WE JUST GAVE A SAMPLE TO THE REPRESENTATIVE FROM THE SAME BATCH. SURGEON¿S NAME- DR. (B)(6).

    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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE. 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: IF OTHER, DESCRIBE EXCISION CANCER LOWER EYELID SURGERY, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT (B)(6), WAS DEVICE EXPLANTED? FALSE, DID PATIENT REQUIRE REVISION SURGERY? TRUE, REASON FOR REVISION SURGERY. SIGNS OF SURGICAL SITE INFECTION - RED, PAINFUL, SWOLLEN EYELID, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? SIGNS OF SURGICAL SITE INFECTION - RED, PAINFULL, SWOLLEN EYELID. 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 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)? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL INFECTION). PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE. 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 CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE ARE THERE ANY PHOTOS AVAILABLE? 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? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. SURGEON¿S NAME?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXCISION CANCER LOWER EYELID SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. UPON INVESTIGATION, THE ONLY COMMON FACTOR IDENTIFIED AMONG THE CASES IS THE USE OF SPECIFIC SUTURES. SURGEON CONVERTED TO THIS SUTURE AND HAS BEEN USING AND DOING THESE PROCEDURES FOR MORE THAN 5 1/2 YEARS. THE HOSPITAL IS ALSO CURRENTLY BUSY WITH OWN INVESTIGATION OF TAKING SWABS IN CSSD, SETS AND THEATRES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865752 VICRYL RAP UND 45CM M0.7 USP6/0 SGLE ARMED P-1 PRIME SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AW5003

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention