BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFXSPI MCL+ UNI UD 24IN 3-0 SA PS-1 PMP

    MDR report key: 19660200 · Received July 2, 2024

    Report

    Report Number
    2210968-2024-06850
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 2, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031236622
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # PC-(B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED ADDITIONAL INFORMATION PROVIDED: SHE USED STRATAFIX ON ALL LAYERS OF CLOSURE. THE STRATAFIX ON THE SKIN LAYER IS STILL INTACT BUT THERE WAS BLEEDING COMING THROUGH, MORE THAN USUAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT IS THE ALLEGED PRODUCT COMPLAINT/ISSUE WITH ADHESIVE AND OR STRATAFIX UNKNOWN SUTURE? THERE WAS A CONCERN IF THE WOUND WAS SEALED PROPERLY. NAME OF KNEE SURGERY? TOTAL KNEE ARTHROPLASTY WHAT WAS THE PROCEDURE DATE? MAY 3, 2024 WHAT DATE /DAY POST OP WAS THE ISSUE NOTED? MAY 8, 2024 WAS ANY SURGICAL INTERVENTION PERFORMED? NO WERE ANY CULTURES TAKEN? RESULTS? NO PLEASE DESCRIBE HOW WAS THE ADHESIVE WAS APPLIED. PROPER TECHNIQUE PER IFU. WHAT PREP WAS USED PRIOR TO, DURING OR AFTER ADHESIVE USE? UNABLE TO COMMENT. WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE OF COVER DRESSING USED? UNABLE TO COMMENT. IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? NO KNOWN ALLERGIES. IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? NO WAS PATIENT SCREENING DONE PRIOR THE PROCEDURE, E.G. CHECK PATIENT NOT ALLERGIC TO CYANOACRYLATE, FORMALDEHYDE, BAC, PRESSURE-SENSITIVE ADHESIVE? YES. PATIENT DEMOGRAPHICS: INITIALS / ID, GENDER, AGE OR DATE OF BIRTH; BMI UNABLE TO COMMENT. PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS) UNABLE TO COMMENT. HAS THE PATIENT USED OR BEEN EXPOSED TO SIMILAR GLUES/AGENTS FOR REPAIR, CRAFTS, COSMETIC USE (LASHES, NAILS)? UNABLE TO COMMENT. WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? UNABLE TO COMMENT. PRODUCT CODE AND/OR LOT OF PRODUCT USED. CLR222US CURRENT PATIENT STATUS. GOOD. NAME OF SURGEON? DR. RENEE SMITH WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? IMPROPER TECHNIQUE WHEN CLOSING STRATAFIX MONOCRYL. IS PRODUCT AVAILABLE TO RETURN FOR ANALYSIS.NO WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? NO DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? UNABLE TO COMMENT. WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. NO HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? SIGNIFICANT AMOUNT OF DRAINAGE. PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. STRATAFIX PRODUCT CODE AND OR LOT? SXPP1A404, SXMP1B103 NO PRODUCT IS AVAILABLE FOR RETURN. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE® ACTIVE INGREDIENT(S) ¿ TRICLOSAN DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL STRENGTH ¿ = 2360 ¿G/M 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN ORTHOPEDIC KNEE PROCEDURE ON AN (B)(6)2024 AND BARBED SUTURE WAS USED. SURGEON CLOSED A PATIENT LAST FRIDAY AND DEVELOPED A LOT OF BLOODY DRAINAGE, AS IT WAS SOAKING THROUGH THEIR BED SHEETS. THE SURGEON INITIALLY THINKS THAT THE INCISION IS ACTUALLY NOT SEALED AND THEREFORE ALSO NOT SOMETHING SHE WANTS TO GET WET. THE SKIN AROUND THE INCISION LOOKS GREAT, WHICH CAN POTENTIALLY RULE OUT THE THOUGHTS OF A REACTION. THIS IS BLEEDING THROUGH THE INCISION SITE. CURRENTLY, THE BLEEDING HAS DECREASED AND THE PATIENT WENT HOME WITH A NEW DRESSING OVER IT AND WAS PUT ON ANTIBIOTICS UNTIL IT STOPS ACTIVELY BLEEDING. DEVICE AVAILABILITY UNKNOWN. SURGEON OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT, IMPROPER TECHNIQUE WHEN CLOSING BARBED SUTURE.ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526125 SFXSPI MCL+ UNI UD 24IN 3-0 SA PS-1 PMP SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID GAM ETHICON INC. 10705031236622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention