BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDSII VIO 18IN 4-0 S/A PS-2 PRM MP

    MDR report key: 17295577 · Received July 10, 2023

    Report

    Report Number
    2210968-2023-04943
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    February 27, 2023
    Report Date
    July 10, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031061354
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DATE: (B)(6) 2023. PT ID: AW. PROCEDURE: BREAST IMPLANT EXCHANGE; MASTOPEXY, GALAFLEX OTHER COMPLICATION: R IMPLANT MALPOSITION. SUTURE: PDS. OTHER RELEVANT PT HISTORY (HTN, DIABETES, SMOKER, PREVIOUS MRSA OR STAPH INF.): ASTHMA; GSASTRIC SLEEVE AGE: 28, GENDER: F, WEIGHT: 158, HEIGHT (IN): 5'6, PRE-OP CLEANSING PROCEDURE: SHOWER WITH HIBICLENS. PREEXISTING INF. SIGNS/SYMP: NO. SURGICAL APPROACH: OPEN TISSUE IN WHICH SUTURE WAS USED: BREAST SKIN. PRE-OP TISSUE CONDITION: NORMAL. SUTURE DEFICIENCY NOTED BY SURGEON DURING PROCEDURE(S): NO. PERI-OPERATIVE ABX: YES, 30" PRIOR TO INCISION, PO X 5 DAYS POSTOP. ONSET DATE/TIME INF.: (B)(6) 2023. DRAINAGE TYPE/AMOUNT: NONE. INF. SIGNS/SYMP: SLIGHT EXCORIATION TO "T" INCISION. CULTURES PERFORMED? (ADD DETAILS, IF YES- NEED LAB RECORD):NO. OTHER DETAILS: (B)(6) 2023 PT PRESENTED WITH RT IMPLANT SEVERLY MALPOSITIONED SUPERIORLY; RETURNED TO OR (B)(6) 2023 FOR RT BREAST EXPLORATION; (B)(6) 2023 SLIGHT EXCORATIN @ "T" INCISIONS, TREATED W/ PEROXIDE, POLYSPROIN AND BANDAIDS; (B)(6) 2023 PT STILL HAD BREAKDOWN AT "T" INCISIONS, PRESCRIBED SILVADENE OINTMENT; (B)(6) 2023 PT REPORTED LT "T" INCISION WAS HEALED; (B)(6) 2023 PT WAS 5 MONTHS POST-OP AND STILL HAD ERYTHEMA, GIVEN SILAGEN TOPICAL WOUND CARE ONLY: PEROXIDE, POLYSPORIN, BANDAID; SILVADENE; SILAGEN PO ANTIBIOTICS: NO. RETURN TO OR (Y OR N): Y. CURRENT STATUS: RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT DEVELOPED SIGNS OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261056 PDSII VIO 18IN 4-0 S/A PS-2 PRM MP SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. Z513G 10705031061354

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention