BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL

    MDR report key: 24775438 · Received April 3, 2026

    Report

    Report Number
    2210968-2026-03440
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    January 1, 2026
    Report Date
    April 24, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031042018
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) 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: H6 HEALTH EFFECT - CLINICAL CODE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE FOLLOWING INVESTIGATION HAS BEEN NARROWED DOWN TO 5 CODES: J417H, J416H, J339H, J869H, J957H. WHAT IS THE PRODUCT FAMILY/PRODUCT CODE ASSOCIATED WITH THIS REPORTED ISSUE(S)? J957H ¿ 2-0, UNDYED, J416H ¿ 3-0, UNDYED, J869H ¿ 2-0, UNDYED, J417H ¿ 2-0, UNDYED, J339H ¿ 2-0. ALL SUTURES WERE APPLIED USING AN INTERRUPTED TECHNIQUE SUTURES BECOME NOTICEABLE AT APPROXIMATELY 4¿6 WEEKS POST-OP AROUND 10 WEEKS POST-OP, SUTURES HAVE BEEN OBSERVED TO SPIT OR BLISTER SOME CASES HAVE LED TO INFECTION, WHILE OTHERS HAVE NOT IT IS DIFFICULT TO DETERMINE WHETHER THE SUTURE ACTED AS A NIDUS FOR INFECTION APPROXIMATELY 12¿15 PATIENTS HAVE RETURNED WITH SIMILAR CONCERNS IN MOST CASES, KNOTS WERE REMOVED; IN SOME INSTANCES, INDIVIDUAL SUTURE STRANDS WERE REMOVED. NONE OF THE AFFECTED PATIENTS WERE NOTED TO BE ON STEROIDS TYPICAL 1¿2 MONTH POST-OPERATIVE RECOVERY PERIODS HAVE EXTENDED CLOSER TO 2 MONTHS HE IS OBSERVING THESE ISSUES AT TIMES UP TO TWICE DAILY, WHICH IS A NOTICEABLE INCREASE COMPARED TO PREVIOUS EXPERIENCE. HE SUSPECTS THIS MAY BE RELATED TO AN ABSORPTION ISSUE ARE SURGICAL PROCEDURE OR DEVICE PHOTOGRAPHS/VIDEOS AVAILABLE FOR REVIEW? NO ADDITIONAL INFORMATION? NONE AT THIS TIME. AS WE COULD NOT CONFIDENTLY IDENTIFY WHETHER A SPECIFIC 2-0 OR 3-0 CODE WAS THE PRIMARY SOURCE OF CONCERN, ALL SUSPECTED CODES WERE SENT FOR FURTHER INVESTIGATION. ONE OF THE ADDITIONAL POINTS THAT THE CUSTOMER SHARED WAS THAT WHEN THEY OBSERVED INTACT SUB Q 2.0 VICRYL AT THE 6-WEEK FOLLOW UP MARK, THE SUTURES LOOKED FULLY INTACT. THEY ALSO STATED THAT A RECENT PATIENT PRESENTED WITH NON-ABSORBED 2.0 VICRYL (SUB Q) AT APPROXIMATELY 70 DAYS POST OP. THIS WAS OBSERVED AS THE PATIENT PRESENTED WITH A WOUND THAT WAS NOT HEALING AS EXPECTED, AND ON INVESTIGATION THE WOUND WAS OBSERVED TO BE PARTLY DEHISCED. IN THE DEHISCED AREA, 2.0 UNDYED VICRYL WAS OBSERVED TO BE FULLY INTACT IN THE SUB Q TISSUE PLANE. THE PATIENT WAS SUBSEQUENTLY REOPERATED ON DUE TO A FAILED INITIAL PROCEDURE.

    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. 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: ¿THE ONLY HELP WE CAN PROVIDE FROM THE CLINIC WOULD BE AN APPROXIMATION OF HOW MANY PATIENTS HAVE COME IN WITH THIS ISSUE. WE HAVE, ON OCCASION, HAD THE ODD PERSON COME IN WITH A BIT OF A STITCH ABSCESS AND THESE WERE ALL ATTRIBUTED TO THE ABSORBABLE SUTURES IN QUESTION. THEY WERE RANDOM AND INFREQUENT, SO IT REALLY DIDN¿T SEEM LIKE AN ISSUE. HOWEVER, OVER THE PAST 4 OR SO MONTHS, WE ARE SEEING A LOT OF THEM. I WOULD GUESS THAT WE HAVE SEEN AT LEAST 15 OF THEM THROUGH THE BONE AND JOINT CLINIC. IT IS NOT DOCTOR SPECIFIC AS WE ARE SEEING THEM FROM ALL OF OUR SURGEONS. IT ALSO DOESN¿T SEEM TO BE PROCEDURE SPECIFIC AS WE ARE SEEING DELAYED ABSORPTION OR ABSCESSES IN MULTIPLE SURGICAL PROCEDURES. THESE SPECIFIC PATIENTS ARE EXPERIENCING DELAYED HEALING, PAIN, INFECTIONS, AND LONG-TERM ANTIBIOTICS FROM SOME OF THESE NON-ABSORBING SUTURES¿ ¿MORE RECENTLY I HAVE NOTICED IT WITH A HIP CASE - #1 OR 2-0 UNDYED, AND A FOOT CASE 3-0 UNDYED; I CAN¿T COMMENT ON OTHER SURGEONS¿ CASES. BUT LOOKING BACK, IT APPEARS THIS IS BECOMING A MORE COMMON FINDING THAN BEFORE¿¿ ¿KELLY HERE IN BONE AND JOINT. 3 OF MY DOCS ARE NOTICING THE DISSOLVING LINE OF VICRYL SUTURES DOESN¿T SEEM TO BE DISSOLVING?? 2 FOR TUNG TODAY, ALONG WITH A COUPLE FROM BOTH BOTSFORD AND MCINTYRE IN THIS LAST 2 WEEKS. I KNOW YOU HAVE A MILLION THINGS ON OUR PLATE, BUT THEY JUST WANTED YOU TO BE AWARE. IT DOESN¿T SEEM TO BE ANY SPECIFIC VICRYL SINCE IT¿S BEEN A 4.0, 3.0 AND 2.0 IN THE CASES WE HAVE SEEN, BUT THEY HAVE ALL BEEN DISSOLVING SUTURES THAT HAVEN¿T DISSOLVED. THE DOCS JUST THOUGHT THEY WOULD LIKE YOU TO BE AWARE OF THIS IN CASE IT BECOMES A CONSISTENT PATTERN?¿ ¿BELOW ARE THE MOST USED VICRYL SUTURES BY OUR ORTHOPEDIC SURGEONS. I MOSTLY PULLED FROM OUR PREFERENCE CARDS FOR HIP/KNEE ARTHROPLASTY AS WELL AS ANKLE FRACTURES. KRISTY ONE OF OUR ORTHO RESOURCES NURSES ALSO CONFIRMED THAT THESE WERE THE MOST COMMONLY USED. HOPE THIS HELPS!¿ I AM STILL SEEKING COLLATERAL FROM OUR PHYSICIAN TEAM; SEVERAL ARE OFF ON LEAVES AND THAT IS PROVING A BIT OF A BARRIER. 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. HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, COULD YOU PLEASE PROVIDE THE CORRESPONDING REFERENCE NUMBER(S)? WHAT WAS THE DATE OF THE PROCEDURE (IMPLANTATION DATE)? ON WHAT DATE WAS THE SLOW ABSORPTION FIRST IDENTIFIED OR DIAGNOSED? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-SUTURING; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. COULD YOU TELL ME IF THERE WAS A PRESCRIPTION FOR STEROIDS OR ANTIBIOTICS FOR THE PATIENT¿S RECOVERY? IF YES, PLEASE PROVIDE MEDICATION NAME, ROUTE AND DOSE. WHAT IS THE CURRENT STATUS OF THE PATIENT? PLEASE CONFIRM: IS THE CORRECT QUANTITY OF PATIENTS 15? IF THERE ARE MORE THAN 15 PATIENTS, PLEASE CREATE ONE PRODUCT COMPLAINT PER ADDITIONAL PATIENT. PLEASE CLARIFY THIS STATEMENT: ¿WE HAVE, ON OCCASION, HAD THE ODD PERSON COME IN WITH A BIT OF A STITCH ABSCESS AND THESE WERE ALL ATTRIBUTED TO THE ABSORBABLE SUTURES IN QUESTION. THEY WERE RANDOM AND INFREQUENT, SO IT REALLY DIDN¿T SEEM LIKE AN ISSUE¿ ARE THE ABSORBABLE SUTURES REFERRED TO IN THIS STATEMENT ETHICON SUTURES? IF YES, HOW MANY PATIENTS DOES THIS STATEMENT REFER TO? IF YES, ARE THE PATIENT(S) INCLUDED IN THE LIST OF THE 15 FILES ABOVE? HAVE THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE PRODUCT COMPLAINT NUMBER. PLEASE PROVIDE THE FOLLOWING FOR EACH PATIENT: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. TYPE OF PROCEDURE? DATE AND NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? FOR THE ORIGINAL INTENDED CLOSURE, HOW WERE ALL LAYERS CLOSED? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? PLEASE DESCRIBE THE TIMELINE OF EVENTS, INCLUDING WHEN ISSUES WERE NOTICED AND WHAT WAS DONE. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? ARE ANY PHOTOS AVAILABLE? DID THE PATIENT EXPERIENCE AN ABSCESS? DID THE PATIENT EXPERIENCE A WOUND DEHISCENCE? IF YES, WHAT TISSUE DEHISCED? ONSET DATE/TIME OF DEHISCENCE? (# POST OP DAYS). HOW WAS THE DEHISCENCE MANAGED? PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE). PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE. 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 AND SENSITIVITIES 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. WHAT TYPE OF MEDICATION WAS GIVEN AND REASON FOR THE MEDICATION? 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? SURGEON¿S NAME? PRODUCT CODE AND LOT NUMBER FOR PATIENTS 11 THROUGH 15? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION.

    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: H6 TYPE OF INVESTIGATION A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE SUTURE WAS NOT ABSORBING OR HAD DELAYED ABSORPTION. THE PATIENT MAY HAVE EXPERIENCED DELAYED HEALING, PAIN, INFECTION, AND POSSIBLE LONG TERM ANTIBIOTICS. THE PATIENT MAY HAVE HAD AN ABSCESS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21659 COATED VICRYL SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. 10995T 10705031042018

    Patients

    Seq Age Sex Outcome Treatment
    1