BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX PDS PLUS SUTURE

    MDR report key: 24709137 · Received March 30, 2026

    Report

    Report Number
    2210968-2026-03193
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    April 21, 2025
    Report Date
    March 26, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. 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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: AESTHETIC PLAST SURG. 2025 JUN;49(11):3121-3131. DOI: 10.1007/S00266-025-04877-X. EPUB 2025 APR 21. PMID: 40259068. HTTPS://DOI.ORG/10.1007/S00266-025-04877-X.

    Description of Event or Problem · 0

    THE FOURTH-GENERATION LOWER BODY LIFT: COMBINING TECHNIQUES AND TECHNOLOGIES FOR IMPROVED OUTCOMES IN HIGH-DEMAND FEMALE PATIENTS. THE AIM OF THE STUDY IS TO DESCRIBE THE OUTCOMES AND COMPLICATIONS IN PATIENTS WITH MODERATE TO SEVERE SKIN LAXITY WHO UNDERWENT A COMPREHENSIVE LOWER BODY LIFT (LBL) USING MULTILAYER LIPOSCULPTURE, ABDOMINAL WALL VOLUMIZATION, SKIN RETRACTION TECHNOLOGIES AND BUTTOCKS AUGMENTATION WITH IMPLANTS OR FLAPS. FROM 2021 TO 2024, 32 FEMALE PATIENTS UNDERWENT THIS COMPREHENSIVE APPROACH. AFTER ENSURING HAEMOSTASIS AND VERIFYING THE POCKET DEPTH, WHICH IS FACILITATED BY THE WIDE EXPOSURE, THE DESIRED VOLUME IMPLANT IS INSERTED, AND THE MUSCLE IS CLOSED WITH 3 TO 4 SEPARATE VICRYL 2-0 SUTURES. ONCE THE IMPLANTATION IS COMPLETED, THE GLUTEAL LIFT CLOSURE IS PERFORMED IN 3 LAYERS, USING RUNNING STRATAFIX PDS 1-0 FOR THE SUBCUTANEOUS LAYER, 3-0 FOR THE DERMIS, AND MONOCRYL 4-0 FOR THE INTRADERMAL LAYER. PLICATION IS DONE USING RUNNING STRATAFIX PDS 1-0 IN 2 LAYERS. THE SCARPA¿S FASCIA OF THE PUBIC FLAP IS FIXED TO THE ABDOMINAL WALL WITH SEPARATE VICRYL 1-0 SUTURES TO ACHIEVE THE DESIRED APPEARANCE. THE WOUND IS CLOSED IN LAYERS WITH RUNNING STRATAFIX PDS 2-0 FOR THE SUBCUTANEOUS TISSUE, STRATAFIX PDS 3-0 FOR THE DERMIS, AND STRATAFIX MONOCRYL 3-0 FOR THE SKIN. .¿ REPORTED COMPLICATIONS INCLUDE: VICRYL SUTURES (ETHICON) SEROMA (N=11) TREATMENT: NOT REPORTED MINOR DEHISCENCE (N=7) TREATMENT: 4 WOUND DEHISCENCES HEALED SPONTANEOUSLY, WHILE 3 REQUIRED RESUTURING HEMATOMA (N=1) TREATMENT: NOT REPORTED ANAEMIA (N=2) TREATMENT: 1 WAS TRANSFUSED WITH 2 RED CELLS UNIT WHILE THE OTHER 1 REQUIRED 4 RED CELLS UNIT AND 6 PLATELETS UNIT. STRATAFIX PDS SUTURES (ETHICON) SEROMA (N=11) TREATMENT: NOT REPORTED MINOR DEHISCENCE (N=7) TREATMENT: 4 WOUND DEHISCENCES HEALED SPONTANEOUSLY, WHILE 3 REQUIRED RESUTURING HEMATOMA (N=1) TREATMENT: NOT REPORTED ANAEMIA (N=2) TREATMENT: 1 WAS TRANSFUSED WITH 2 RED CELLS UNIT WHILE THE OTHER 1 REQUIRED 4 RED CELLS UNIT AND 6 PLATELETS UNIT. MONOCRYL (ETHICON) SEROMA (N=11) TREATMENT: NOT REPORTED MINOR DEHISCENCE (N=7) TREATMENT: 4 WOUND DEHISCENCES HEALED SPONTANEOUSLY, WHILE 3 REQUIRED RESUTURING HEMATOMA (N=1) TREATMENT: NOT REPORTED ANAEMIA (N=2) TREATMENT: 1 WAS TRANSFUSED WITH 2 RED CELLS UNIT WHILE THE OTHER 1 REQUIRED 4 RED CELLS UNIT AND 6 PLATELETS UNIT. STRATAFIX MONOCRYL (ETHICON) SEROMA (N=11) TREATMENT: NOT REPORTED MINOR DEHISCENCE (N=7) TREATMENT: 4 WOUND DEHISCENCES HEALED SPONTANEOUSLY, WHILE 3 REQUIRED RESUTURING HEMATOMA (N=1) TREATMENT: NOT REPORTED ANAEMIA (N=2) TREATMENT: 1 WAS TRANSFUSED WITH 2 RED CELLS UNIT WHILE THE OTHER 1 REQUIRED 4 RED CELLS UNIT AND 6 PLATELETS UNIT. IN CONCLUSION, OUR STUDY DEMONSTRATES THE FEASIBILITY AND EFFECTIVENESS OF A COMPREHENSIVE BODY CONTOURING APPROACH THAT ADDRESSES MULTIPLE AESTHETIC CONCERNS SIMULTANEOUSLY. THIS GLOBAL BODY APPROACH NOT ONLY COR RECTS A WIDE RANGE OF ISSUES IN A SINGLE PROCEDURE¿OFFERING SIGNIFICANT ADVANTAGES IN TERMS OF PATIENT CONVENIENCE AND OVERALL SATISFACTION¿BUT ALSO DELIVERS HIGH-END RESULTS FOR COMPLEX PATIENTS WITH MARKED CONTOUR ALTERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769799 STRATAFIX PDS PLUS SUTURE SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25) NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention