VICRYL RAPIDE VR917Recalls & reported problems
Ethicon, LLC · Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of VICRYL RAPIDE (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Vicryl Rapide suture is an absorbable thread used to close wounds, which dissolves in the body over time. Many of the 114 reports describe the thread breaking or fraying during stitching, and some describe poor wound healing, redness, or discharge. The reports include 37 injuries and no deaths. One recall, started in August 2017 after suture damage was found during testing, is closed.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 117
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10705031134768), received between Sep 30, 2019 and Sep 30, 2026 — classified as 37 injuries, 80 malfunctions.
The most frequently reported specific device problem is “Break” (62 reports).
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Aug 17, 2017Terminated
On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing.
Z-0693-2018 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Break62
- Material Integrity Problem30
- Adverse Event Without Identified Device or Use Problem18
- Dull, Blunt11
- Material Separation11
- Component Misassembled2
- Failure to Degrade2
- Material Frayed2
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- Impaired Healing22
- Pain20
- Inflammation16
- Wound Dehiscence15
- Purulent Discharge13
- Post Operative Wound Infection10
- Pocket Erosion9
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. During the procedure, the problem of pulling off suture needle happened. The needle did not fell into the patient. Changed to another one to complete the surgery. There were no adverse patent consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949320 ↗MalfunctionSep 30, 2026Material Separation
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. During the procedure, the problem of pulling off suture needle happened. The needle did not fell into the patient. Changed to another one to complete the surgery. There were no adverse patent consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949310 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient gave birth to a full-term baby through vaginal delivery on (b)(6)2026. The amniotic fluid was clear and the perineum had a degree I laceration. The doctor first sutured the subcutaneous tissue with sutures, and then performed intradermal suturing of the skin with suture . After the suturing was completed, the wound was checked to be well aligned and there was no bleeding. On the third day after surgery, the patient underwent examination and found suspicious exposed suture in the perineum wound. The wound was slightly red and swollen (inflammation), without tearing, and the doctor strengthened local dressing treatment. On the 5th day after the patient's surgery, the perineal wound was slightly red and swollen, with some sutures exposed. The epidermal layer of the wound was cracked by about 3mm and there was exudate. The doctor performed local cleaning and disinfection, removed the exposed sutures, and changed the dressing. Additional information was requested.
Patient problems: Erythema; Fluid Discharge; Inflammation; Pocket Erosion; Swelling/ Edema; Wound Dehiscence
MAUDE report 50329145 ↗MalfunctionAug 4, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132261 ↗MalfunctionMar 13, 2026Break; Failure to Degrade
IT WAS REPORTED A PATIENT UNDERWENT A POST OP VAGINAL DELIVERY SUTURE REMOVAL ON (B)(6) 2025 A SUTURE WAS USED. THE PATIENT CAME TO THE HOSPITAL FOR VAGINAL DELIVERY NOV. 10 AND FELT THAT THE PERINEAL SUTURE WAS PRONE TO TEARING DURING THE DELIVERY ROOM. ON THE 6TH DAY AFTER SURGERY, THE PATIENT CAME TO THE HOSPITAL TO REMOVE THE WOUND SUTURE. DURING THE OPERATION, THE DOCTOR AND NURSE FOUND THAT THE PATIENT'S WOUND HAD NOT HEALED/HAD POOR HEALING, AND THE ABSORBABLE GAP HAD BROKEN. IMMEDIATELY CLEAN THE RESIDUAL GAPS, DISINFECT WITH IODINE SOLUTION, GUIDE THE PATIENT TO SOAK IN IODINE SOLUTION FOR DISINFECTION, PROVIDE DIETARY GUIDANCE, AND RECHECK 7 DAYS LATER. THE WOUND HAS HEALED WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Impaired Healing
MAUDE report 24594972 ↗MalfunctionFeb 24, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A DELIVERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT A LEFT PERINEAL INCISION WITH THE HELP OF FORCEPS TO DELIVER A LIVE BABY. AFTER DELIVERY, THE PERINEAL INCISION WAS CHECKED AND EXTENDED INWARD BY 2CM. THE DOCTOR USED SUTURE TO SUTURE THE INCISION FOR THE PATIENT, BUT DURING THE SUTURE PROCESS, THE SUTURE BROKE, CAUSING MILD DAMAGE TO THE PATIENT'S PERINEAL TISSUE. THE DOCTOR USED ANOTHER SUTURE TO SUTURE THE INJURED BLEEDING AREA IN A TIMELY MANNER, WHICH PROLONGED THE SURGERY TIME AND INCREASED THE PATIENT'S PAIN.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Pain
MAUDE report 24434878 ↗MalfunctionJan 22, 2026Break; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW PERINEUM. BESIDES, THE SUTURE BODY IS HARDER THAN BEFORE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24146034 ↗MalfunctionJan 22, 2026Break; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW PERINEUM. BESIDES, THE SUTURE BODY IS HARDER THAN BEFORE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24146011 ↗MalfunctionJan 22, 2026Break; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW PERINEUM. BESIDES, THE SUTURE BODY IS HARDER THAN BEFORE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145893 ↗MalfunctionJan 22, 2026Break; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW PERINEUM. BESIDES, THE SUTURE BODY IS HARDER THAN BEFORE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145741 ↗MalfunctionJan 21, 2026Break; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW PERINEUM. BESIDES, THE SUTURE BODY IS HARDER THAN BEFORE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 26 REPRESENTATIVE SAMPLES FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136832 ↗MalfunctionJan 21, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AFTER THE PATIENT GAVE BIRTH, THE DOCTOR USED SUTURE TO SUTURE THE WOUND. DURING THE SUTURE PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NO LONGER BE USED. AFTER TYING THE KNOT, OPEN THE NEW SUTURE AND CONTINUE SEWING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24135976 ↗MalfunctionJan 6, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 23:35, MEDICAL STAFF USED SUTURE DURING DELIVERY ON STAGE AND FOUND THAT THE SUTURE BROKE EASILY WHEN CLAMPED WITH HEMOSTATIC FORCEPS. THE SUTURE WAS EASILY BROKEN. THE MEDICAL STAFF REPLACED IT WITH ANOTHER NEW SUTURE OF THE SAME BATCH NUMBER AND THE PROBLEM NO LONGER OCCURRED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981401 ↗MalfunctionDec 17, 2025Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE TIP WAS FOUND BLUNT WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. PLEASE REFER TO THE ATTACHED PHOTOS OF THE DEFECT PRODUCT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829942 ↗MalfunctionDec 17, 2025Failure to Degrade; Failure to Degrade
IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT GAVE BIRTH TO A BABY GIRL AT FULL TERM AT 04:35 DUE TO "40 * WEEKS OF AMENORRHEA". THE PERINEAL INCISION WAS SUTURED SMOOTHLY WITHOUT ANY OTHER DISCOMFORT, AND THE PATIENT WAS DISCHARGED 2 DAYS LATER. 32 DAYS AFTER THE SURGERY, THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO "PAIN IN PERINEUM, UNCLEAN LOCHIA AND PECULIAR SMELL". THE GYNECOLOGICAL EXAMINATION FOUND POOR HEALING OF THE PERINEAL INCISION, VISIBLE EXPOSED SUTURE. THE LOCAL VULVA WAS CLEANED AND THE SUTURE WAS REMOVED. TWO BOTTLES OF COMPOUND PHELLODENDRON LIQUID COATING WERE GIVEN TO GO HOME AND WASH THE PERINEUM. AFTER 41 DAYS OF SURGERY, THE PATIENT RETURNED TO THE HOSPITAL FOR POSTPARTUM REHABILITATION EVALUATION, AND THE EXAMINATION FOUND THAT THE VULVA WAS NORMAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Impaired Healing; Inflammation; Pain
MAUDE report 23828989 ↗MalfunctionDec 15, 2025Break; Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A DELIVERY SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THIS CASE REFER TO (B)(4), ANOTHER COMPLAINT WAS INFORMED IN THIS CASE. DURING THE PERINEAL SUTURE AFTER DELIVERY, THIS BATCH OF SUTURE OF THIS MODEL WAS USED FOR SLIGHT TRACTION AND REPEATED RUPTURE OF BLEEDING. AFTER THE SUTURE WAS REPLACED, THE SUTURE WAS COMPLETED, WITHOUT CAUSING HARM TO THE PATIENT. ALSO FEEDBACK THAT THE SUTURE IS STIFFER THAN BEFORE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802151 ↗MalfunctionDec 15, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A DELIVERY SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE PREGNANT WOMAN STOPPED MENSTRUATING FOR 38W, HAD VAGINAL REDNESS FOR 1 DAY, AND HAD VAGINAL FLUID FLOW FOR MORE THAN 1 HOUR BEFORE BEING ADMITTED AT 15:41. THE ADMISSION DIAGNOSIS WAS: 1. PREMATURE RUPTURE OF MEMBRANES. 2. PREGNANCY COMPLICATED WITH HYPOTHYROIDISM. 3. PREGNANT AT 38 WEEKS. 4. PREGNANT 5 TIMES. 5. PRODUCE TWICE. 6. PREGNANCY SUPERVISION FOR ELDERLY MULTIPAROUS WOMEN. 7.THE UMBILICAL CORD WRAPS AROUND THE NECK ONCE. 21:42 DELIVERY, PERINEAL I DEGREE LACERATION AFTER DELIVERY, SUTURED WITH SUTURE. DURING THE SUTURING PROCESS, THE SUTURE WAS GENTLY PULLED AND REPEATEDLY BROKEN. AFTER REPLACING THE SUTURE, THE SUTURING IS COMPLETED. BEFORE THE PATIENT LEAVES THE CLINIC, THE DOCTOR RECHECKS THE WOUND FOR ANY BROKEN SUTURES OR ACTIVE BLEEDING CAUSED BY LOOSE SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802042 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2025 AND SUTURE WAS USED. AT 08:15, DURING THE PERINEAL SUTURING PROCESS, THE SUTURE BROKE DURING KNOTTING, MAKING IT IMPOSSIBLE TO CONTINUE SUTURING. ANOTHER SUTURE WAS REPLACED TO CONTINUE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23697257 ↗MalfunctionNov 25, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT VAGINAL DELIVERY ON (B)(6) 2025 AND SUTURE WAS USED ON THE PERINEUM. WHILE SUTURING THE PATIENT'S PERINEUM, THE SUTURE FREQUENTLY BROKE, RESULTING IN INCREASED DIFFICULTY IN SUTURING, PROLONGED OPERATION TIME, AND INCREASED PATIENT PAIN. REPLACED THE SUTURE AND COMFORTED THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Pain
MAUDE report 23646192 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY WITH ROUTINE PERINEAL INCISION ON (B)(6) 2025 AND SUTURE WAS USED. ON THE 5TH DAY AFTER SURGERY, (B)(6) 2025, THE PERINEAL INCISION SUTURE WAS REMOVED, AND IT WAS FOUND THAT THE INCISION SITE WAS SLIGHTLY RED AND PAINFUL. NO WOUND WAS FOUND TO HAVE OPENED, INDICATING A FOREIGN BODY SENSATION OR REJECTION REACTION OF THE SUTURE. FIVE DAYS AFTER DISCHARGE, THE PATIENT FOUND PAIN AND DISCOMFORT IN THE PERINEAL WOUND. ON THE 12TH DAY AFTER SURGERY (B)(6) 2025, THE PATIENT VISITED THE OUTPATIENT DEPARTMENT AND CHECKED THAT THE PERINEAL INCISION WOUND HAD OPENED BY ABOUT 2CMX0.3CMX0.1CM, WITH NO ABNORMAL SECRETION EXUDING. THE DOCTOR GAVE YISHAYADING WET COMPRESS TO THE WOUND+REHABILITATION NEW LIQUID WET COMPRESS TO THE WOUND AND INSTRUCTED THE PATIENT TO CLEAN THE PERINEUM WITH WATER AFTER TWO BOWEL MOVEMENTS. THE PATIENT LAY FLAT ON THE RIGHT SIDE AS MUCH AS POSSIBLE. AFTER ONE WEEK, THE WOUND GRADUALLY HEALED. NO REDNESS OR SWELLING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Erythema; Foreign Body Reaction; Inflammation; Pain; Wound Dehiscence
MAUDE report 23547914 ↗MalfunctionSep 18, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE MIDWIFE PERFORMED PERINEAL SUTURING FOR THE PARTURIENT AND FOUND THAT THE SUTURE HAD BROKEN MULTIPLE TIMES WHEN KNOTTED. A NEW SUTURE WAS IMMEDIATELY REPLACED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085269 ↗MalfunctionAug 27, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR DELIVERY. AFTER SMOOTH DELIVERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SUTURE OF GRADE I LACERATION, AND THE SUTURE COULD NOT BE CONTINUED. THE STANDBY SUTURE WAS IMMEDIATELY OPENED AND SUTURED AGAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22907252 ↗MalfunctionJul 28, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT DELIVERED A LIVE BABY VAGINALLY. DURING DELIVERY, THERE WAS A GRADE I PERINEAL LACERATION. THE DOCTOR USED SUTURE TO SUTURE THE PERINEAL LACERATION AND STOP THE BLEEDING. THE SUTURE PROCESS WENT SMOOTHLY, AND THE PERINEAL WOUND WAS IRRADIATED WITH INFRARED RADIATION AND WASHED TO MAINTAIN CLEANLINESS AND HYGIENE. ON THE THIRD DAY AFTER SURGERY, IT WAS FOUND THAT THE PERINEAL WOUND HAD POOR HEALING, WITH POORLY ABSORBED SUTURES AND SOME EXPOSED SUTURES. THE EXPOSED SUTURE WAS REMOVED. ON THE SEVENTH DAY AFTER SURGERY, THE PATIENT'S PERINEAL WOUND STILL HAD POOR HEALING AND NEW EXPOSED SUTURE WAS REMOVED AGAIN. CONSIDERING THAT PREGNANT WOMEN MAY HAVE VAGINITIS BEFORE DELIVERY, VAGINAL BLEEDING AFTER DELIVERY CAN LEAD TO POOR WOUND HEALING AND DIFFICULTY IN ABSORBING SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Impaired Healing
MAUDE report 22635703 ↗MalfunctionJul 16, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT WAS HOSPITALIZED IN OUR HOSPITAL FOR DELIVERY. THE SUTURE BROKE DURING THE SUTURING OF THE PERINEAL WOUND. AFTER THE SUTURE WAS REPLACED, IT WAS SUTURED AGAIN, BUT IT BROKE AGAIN. AFTER THE SUTURE WAS REPLACED FOR THE THIRD TIME, THERE WAS NO BREAKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22518641 ↗MalfunctionJul 16, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT WAS HOSPITALIZED IN OUR HOSPITAL FOR DELIVERY. THE SUTURE BROKE DURING THE SUTURING OF THE PERINEAL WOUND. AFTER THE SUTURE WAS REPLACED, IT WAS SUTURED AGAIN, BUT IT BROKE AGAIN. AFTER THE SUTURE WAS REPLACED FOR THE THIRD TIME, THERE WAS NO BREAKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22518632 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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