BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 17785678 · Received September 20, 2023

    Report

    Report Number
    2210968-2023-06958
    Event Type
    Injury
    Date Received
    September 20, 2023
    Date of Event
    August 1, 2011
    Report Date
    October 18, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    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: I RECENTLY HAD SURGERY AND HAD TO CONVINCE THE DOCTOR I WAS ALLERGIC OR VERY SENSITIVE TO PROLENE. THE FIRST DOCTOR ON (B)(6)2023 USED 409 STITCHES - NO PROBLEM PLUS 3M MICROPORE TAPE WHICH I BROUGHT ALONG. I HAD MOHS SURGERY (B)(6) 2023 FOR THE SAME CANCEROUS TUMOR. I DON'T KNOW THE NAME OF THE STITCHES - I KNOW SHE DIDN'T USE PROLENE BUT THE SENSATIONS I AM HAVING RIGHT NOW I HAVE NO IDEA IF STITCH RELATED YET. REVIEW OF MEDICAL RECORDS SENT BY CUSTOMER FROM SUTURING OF RIGHT LEG LACERATION PROCEDURE ON (B)(6) 2011. DATE OF BIRTH - 1/07/1940 HEIGHT 65 IN, WEIGHT 148LBS FEMALE MEDICAL HISTORY: HTN, OSTEOPOROSIS, DVT, CATARACTS SURGICAL HISTORY - BACK SURGERY L5S1 LAMINECTOMY ALLERGIES: NEOMYCIN (CRITICAL) PROLENE STITCHES (CRITICAL) GENTAMICIN EYE DROPS(CRITICAL) ZADITOR AND TOBRADEX ALL EYE SOLUTIONS FOR CONTACTS AND ANY LUBRICATING EYE DROPS THAT HAVE PRESERVATIVES BENZOIN COMPOUNDS (CRITICAL) ADHESIVE TAPE (CRITICAL) (SEVERE DERMATITIS) TINCTURE OF BENZOIN THAT MAKES STERI STRIPS STICKIER BENZETHONIUM CHLORIDE IN SALINE WASH AND LUBRICANT EYE DROPS YOGA MAT - SEVERE DERMATITIS ON BOTTOM OF FEET BACTROBAN BABY ASPIRIN 1X DAY (CRITICAL) CAUSED BRUISING NABUMETOME (CRITICAL) CHEST PAINS HIBICLENS AND OTHER MEDICAL SCRUBS NEED TO BE WELL RINSED AFTER THE NEED IS OVER. SIGNS OF IRRITATION AND PEELING IF LEFT ON AFTER USE. REAL PERFUMES (HIVES) SUPER GLUE USED ON FINGER SPLITS CRAYOLA CRAYONS (1940S) RAW PEELING FINGERS MOXIBUSTION THERAPY USING STICK-ON MOXA THE ALLERGIC REACTION WAS DUE TO THE ADHESIVE ON THE MOXA, (SEVERE DERMATITIS) THIS MAY SOUND SILLY BUT IN THE 60S/70S I COULD NOT HANDLE FABRIC AND BEFORE SEWING IT HAD TO BE WASHED. IT WAS THE FORMALDEHYDE. (B)(6) 2011 ¿ X RAY OF LEFT WRIST. FINDINGS SUGGESTIVE OF VERY SUBTLE PERIARTICULAR OSTEOPENIA. ADDITIONALLY, THERE APPEARS TO BE SOME CALCIFICATION IN THE EXPECTED LOCATION OF THE TRIANGULAR FIBROCARTILAGE COMPLEX. THIS RAISES THE POSSIBILITY OF CPPD AND RHEUMATOID AND CLINICAL CORRELATION IS SUGGESTED. (B)(6) 2023 INJURY TO RIGHT LEG. THE INJURY HAPPENED JUST PRIOR TO ARRIVAL. OCCURRED AT HOME. CAUGHT LEG ON RUSTY METAL PROTRUDING FROM GROUND. PATIENT IS EXPERIENCING MILD PAIN. NO OTHER INJURY. UNDERWENT LACERATION REPAIR WITH LOCAL ANESTHESIA AND SUTURE. LACERATION INVOLVED FASCIA. CONTAMINATION PRESENT. DOES NOT INVOLVE THE MUSCLE. CONTUSED TISSUE PRESENT. (B)(6) 2011 RIGHT LEG WOUND WITH SUTURES IN PLACE, SLIGHT SEROUS DRAINAGE. SMALL BRUISED AREA TO WOUND AND ECCHYMOSIS TO MEDIAL HEEL. RIGHT SHOULDER OVER VACCIN, SITE WITH SCATTERED ECCHYMOSIS (PT ON ASPIRIN) PROGRESS NOTE (B)(6) 2011 WOUND WITH RED GRANULAR TISSUE AND SCANT SLOUGH. PERIWOUND INTACT SCATTERED SUPERFICIAL VARICOSITITES NAILS SMOOTH. PROGRESS NOTE (B)(6) 2011 WOUND PRESENTS AS A FULL THICKNESS VENOUS ULCER LOCATED ON THE RIGHT, LATERAL, ANTERIOR, LOWER LEG. THERE IS NO TUNNELING OR UNDERMINING NOTED. THERE IS A SCANT AMOUNT OF SEROUS DRAINAGE NOTED WHICH HAS NO ODOR. THERE IS 26-50% ADHERENT, YELLOW SLOUGH AND 51-75% BRIGHT RED, FIRM GRANULATION WITHIN THE WOUND BED. THE WOUND IS IMPROVING. SANTYL OINTMENT DAILY. PROGRESS NOTE (B)(6) 2011 WOUND PRESENTS AS A FULL THICKNESS VENOUS ULCER LOCATED ON THE RIGHT, LATERAL, ANTERIOR, LOWER LEG. THERE IS NO TUNNELING OR UNDERMINING NOTED. THERE WAS NO DRAINAGE NOTE. THERE IS 76-100% EPITHIALIZATION WITHIN THE WOUND BED; NO ADHERENT, YELLOW SLOUGH PRESENT. THE WOUND IS IMPROVING. SANTYL OINTMENT DAILY. PROGRESS NOTE (B)(6) 2011 FOLLOW UP VISIT. INJURED RIGHT LEG SUSTAINING A LACERATION AUG 6TH. WOUND SUTURED BUT DEHISCED DUE TO ¿REACTION TO PROLENE¿. WOUND REMAINS CLOSED. CLEANSE WITH MILD SOAP AND WATER.

    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. 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 SEND YOUR 2011 MEDICAL FILE THAT YOU REFERENCED WHEN YOU CONTACTED US. PLEASE PROVIDE ANY FURTHER INFORMATION ABOUT YOUR SERIOUS ALLERGIC ENCOUNTER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. THE PATIENT HAD A SERIOUS ALLERGIC ENCOUNTER WITH THE SUTURE. THE WOUND WAS SUTURED BUT DEHISCED DUE TO REACTION TO THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614742 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other