BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK BRD BLK 15X60CM M1.0

    MDR report key: 20733779 · Received November 20, 2024

    Report

    Report Number
    2210968-2024-12213
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    November 9, 2024
    Report Date
    November 20, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    16921799018018
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED 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. 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)? DID THE PATIENT DEVELOP A POST-OP INFECTION? 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. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? 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?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL AND MAXILLOFACIAL SOFT TISSUE DEBRIDEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED INFLAMMATION. UPON ADMISSION, THE PATIENT HAD A SKIN LACERATION ON THE LEFT FACE ACCOMPANIED BY A NASAL INJURY. THE PATIENT IMMEDIATELY FELT PAIN AND BLEEDING IN THE LEFT FACE AND NOSE, WITHOUT CONSCIOUSNESS DISORDER, HEADACHE AND OTHER DISCOMFORT. THE PATIENT UNDERWENT THE PROCEDURE AND THE WOUND WAS SUTURED WITH SUTURE. ON THE FIFTH DAY AFTER SURGERY, THE PATIENT COMPLAINED OF REDNESS, SWELLING, AND PAIN AT THE SUTURE SITE OF THE LEFT EYE WOUND. UPON PHYSICAL EXAMINATION, REDNESS AND SWELLING WERE OBSERVED AT THE WOUND SITE OF THE SUTURED SKIN, WITH INCREASED PURULENT DISCHARGE FROM THE INNER CANTHUS OF THE LEFT EYE AND NO DETACHMENT OF THE SUTURE. INTRAVENOUS INFUSION OF INJECTABLE OXACILLIN SODIUM FOR ANTI-INFECTION, STRENGTHENING LOCAL DRESSING CHANGES, GENTAMICIN SULFATE FLUOROMETHOLONE EYE DROPS, AND LEVOFLOXACIN HYDROCHLORIDE EYE GEL WERE GIVEN FOR EYE APPLICATION. ON THE SECOND DAY AFTER MEDICATION, THE PATIENT REPORTED THAT THE PAIN AND ITCHING SYMPTOMS OF THE LEFT EYE WOUND HAD EASED. UPON PHYSICAL EXAMINATION, THERE WAS NO BLOOD OR FLUID LEAKAGE AT THE SUTURE SITE, AND THERE IS NO REDNESS OR SWELLING AROUND THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008813 SILK BRD BLK 15X60CM M1.0 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. SJ5AE 16921799018018

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention