Dextile DXT1510ARRecalls & reported problems
Sofradim Production · Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side · Class 2 · Implant
Quick summary
This Dextile DXT1510AR is a pre-shaped polypropylene surgical mesh used to repair groin hernias. The 28 reports mostly describe ongoing pain in the groin, abdomen, legs or testicles after implantation, along with adhesions, burning or heaviness at the implant site, and in a few cases the mesh shifting, tearing, or having to be removed in revision surgery. No deaths were reported; 20 reports involved injuries. No recalls name this device.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884521726512), received between Apr 15, 2021 and Sep 28, 2026 — classified as 20 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem24
- Insufficient Device Problem Information2
- Migration or Expulsion of Device2
- Patient Device Interaction Problem2
- Degraded1
- Detachment of Device or Device Component1
- Material Deformation1
- Material Split, Cut or Torn1
Patient problems
- Pain17
- Hernia10
- Unspecified Tissue Injury6
- Abdominal Pain4
- Adhesion(s)4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Discomfort3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50925397 ↗MalfunctionJun 5, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, APPROXIMATELY TWO WEEKS AFTER THE OPERATION OF BILATERAL LAPAROSCOPIC INGUINAL HERNIA (TEPP) CURE WITH RIGHT ILIAC DISSECTION, THERE WAS AN APPEARANCE OF INTENSE BURNS IN THE THIGHS, A REAPPEARANCE OF THE SAME PAINS (SOMETIMES STRONGER) IN THE HERNIAS BEFORE THE OPERATION, AND BIG PAINS IN THE LOWER ABDOMEN ON BOTH SIDES. IT WAS ALSO NOTED THAT THE PATIENT REPORTED THE PRESENCE OF LEFT INGUINAL PAIN ON ADMISSION WITH A LEFT HERNIA TIP ON A CLINICAL EXAMINATION. MOREOVER, SINCE THE ONSET OF THE PAIN, THE BURNS IN THE THIGHS HAVE DECREASED BUT HAVE NOT DISAPPEARED. ALL THE OTHER PAINS WERE STILL PRESENT AND HANDICAPPED THE PATIENT IN MY EVERYDAY LIFE.
Patient problems: Burning Sensation; Pain
MAUDE report 25414043 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, PAIN, ADHESIONS, INFECTION, BACTERIAL INFECTION, DISABILITY, DIARRHEA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, MESH REMOVAL, MEDICATION.
Patient problems: Adhesion(s); Bacterial Infection; Diarrhea; Distress; Pain; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 25219337 ↗MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TWO MESHES WERE IMPLANTED FOR TREATMENT OF A BILATERAL LAPAROSCOPIC INGUINAL HERNIA. APPROXIMATELY 1 MONTH AFTER IMPLANTATION, THE PATIENT EXPERIENCED GROIN PAIN, LEG PAIN WITH CRAMPS, AND BACK PAIN. THE PATIENT ALSO REPORTED INTENSE, CHRONIC TIREDNESS CAUSING DISCOMFORT. THE SYMPTOMS REPORTEDLY PROGRESSED FROM THE LEGS TO THE ARMS, WITH ARM SYMPTOMS REPORTED LATER. ANOTHER DEVICE USED WAS FROM COMPETITOR'S SYNTHETIC ADHESIVE.
Patient problems: Back pain; Discomfort; Limb Pain; Pain
MAUDE report 25061110 ↗MalfunctionMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING AN OPERATION FOR AN INGUINAL HERNIA WITH THE INSTALLATION OF THE RIGHT MESH, THE PATIENT EXPERIENCED PAIN DESCRIBED AS BURNING, PINCHING AND HEAVINESS IN THE TESTICLES, WHICH BORDERED ON DISCOMFORT. THE PATIENT WAS EXHAUSTED BY THE CONTINUITY OF PAIN AND REPORTED RESTRICTION IN CARRYING LOADS AT WORK, INITIALLY LIMITED TO 10 KG AND THEN REDUCED TO 6 KG DUE TO PAIN. THE PAIN OCCURRED AT ANY TIME OF THE DAY OR NIGHT, REGARDLESS OF EFFORT OR POSITION.
Patient problems: Discomfort; Pain
MAUDE report 24635803 ↗InjuryJan 27, 2026Migration or Expulsion of Device
IT WAS REPORTED THAT A PATIENT UNDERWENT SURGICAL TREATMENT FOR A RIGHT INGUINAL HERNIA, THE PATIENT EXPERIENCED PERSISTENT GROIN PAIN, ABDOMINAL PAIN, PAIN RADIATING TO THE RIGHT TESTICLE AND RIGHT LUMBAR FOSSA, SIGNIFICANT CONSTIPATION TENDENCY, TINGLING AT THE LEVEL OF THE PROSTHESIS, A FEELING OF SUPPORT AT THE PROSTHESIS SITE, THROBBING PAIN WITH A PAINFUL BACKGROUND, INCREASED FREQUENCYOF URINATION (10¿12 TIMES/DAY FOR 5 DAYS), AND TRACES OF BLOOD ON A URINE STRIP TEST. IMAGING AND CLINICAL SUSPICION INDICATED POSSIBLE MIGRATION OF THE PROSTHESIS, WITH COMPUTED TOMOGRAPHY REVEALING INFILTRATION OF FAT INTO THE RIGHT ILIAC FOSSA AT THE PROXIMAL ORIFICE OF THE RIGHT INGUINAL CANAL. THE PATIENT REPORTED DISABLING PAIN AS AN IMPACT. PRE-EXISTING CONDITIONS INCLUDED FIBROMYALGIA, IRRITABLE BOWEL SYNDROME, VARICOCELE IN THE LEFT TESTICLE, CRYPTORCHIDISM IN CHILDHOOD, AND A HISTORY OF LIGAMENTOPLASTY OF THE LEFT ANKLE. IMAGING ALSO IDENTIFIED A 22 MM HEPATIC CYST. A MEDICATION PRESCRIBE D TAKE.
Patient problems: Infiltration into Tissue; Pain; Unintended Radiation Exposure
MAUDE report 24196442 ↗MalfunctionJan 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING AN OPERATION IN (B)(6) 2021 FOR THE INSTALLATION OF THE LEFT AND RIGHT MESH, POLYPROPYLENE PROSTHESES FOR BILATERAL INGUINAL HERNIAS AT THE GROIN LEVEL, PERSISTENT PAIN AT THE IMPLANT SITE OCCURRED DAILY AND HAS CONTINUED SINCE 2021. THE PAIN WAS DESCRIBED AS MORALLY DISTRESSING AND SOMETIMES MORE INTENSE, REQUIRING STRETCHING OR CHANGES IN POSITION FOR TEMPORARY RELIEF. THE PAIN ALSO HANDICAPPED THE PATIENT'S SEX LIFE, WITH INTENSE PAIN OCCURRING AFTER SEXUAL ACTIVITY, AND IMPACTED PARTICIPATION IN SPORTS, WITH INCREASED PAIN DURING CERTAIN MOVEMENTS. MEDICATION PRESCRIBED FOR NERVE PAIN DID NOT DECREASE THE PAIN, EVEN AT INCREASED DOSES. REHABILITATION WITH A PHYSIOTHERAPIST REDUCED THE PAIN, BUT IT RETURNED QUICKLY IF EXERCISES WERE STOPPED.
Patient problems: Pain; Sexual Dysfunction
MAUDE report 24172267 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Adhesion(s); Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 24122253 ↗MalfunctionNov 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC-ASSISTED INGUINAL HERNIA, AFTER OPENING THE PACKAGING, THE FIRST ASSISTANT NOTICED THAT THERE WAS AN UNUSUAL TEAR ON THE SEALED WEDGES OF THE MESH WHILE PREPARING IT ON THE BACK TABLE. THE MESH WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23457385 ↗InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, FOLLOWING A RIGHT INGUINAL AND CRURAL HERNIA PROCEDURE, THE PATIENT EXPERIENCED SEVERE GROIN AND ABDOMINAL PAIN, DIFFICULTY AND PAIN IN WALKING, FATIGUE, PAIN IN THE PLACE WHERE THE PROSTHESIS WAS IMPLANTED AND INCREASE IN COLONOPATHY.
Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Pain
MAUDE report 22628598 ↗InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A CURE FOR A RIGHT INGUINAL HERNIA AND WAS OPERATED ON (B)(6) 2023 FOR THE INSTALLATION OF THE HERNIA PROSTHESES. IN (B)(6) 2024, THE PATIENT WAS HOSPITALIZED FOR 11 DAYS DUE TO A STOMACHACHE THAT WAS TREATED WITH A HIGH-DOSE ANTIBIOTIC BY INFUSION. THE PATIENT WAS STILL ON ORAL ANTIBIOTICS FOR ANOTHER WHOLE MONTH. THE PATIENT REGULARLY HAD STOMACH PAINS.
Patient problems: Abdominal Pain
MAUDE report 22541252 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POST OPERATIVELY OF A ROBOTIC INGUINAL HERNIA REPAIR, THE DOCTOR STATED THAT THE PATIENT EXPERIENCED A RECURRENCE AFTER THE MESH WAS IMPLANTED.
Patient problems: Hernia
MAUDE report 22232236 ↗InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE INVOLVING THE INGUINAL SPACE, AN INFECTION DEVELOPED ON THE MESH. THE PATIENT HAD THE MESH IMPLANTED AND LATER RETURNED TO THE DOCTOR WITH THE INFECTION. THE INFECTED MESH WAS REMOVED, AND THE PATIENT WAS TREATED AND SENT HOME WITH A DRAIN ON THE SAME DAY. THE EVENT LED TO AN EXTENDED HOSPITALIZATION. AN ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 22120056 ↗InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, ON POST OPERATIVE INGUINAL HERNIA REPAIR SURGERY, THE PATIENT EXPERIENCED CHRONIC PAIN. THE PATIENT FELT THE PRESENCE OF MESH AT ALL TIMES AFTER THE SURGERY. AFTER THREE WEEKS, THE PATIENT FELT RESTRICTION ON RANGE OF MOVEMENT AND CONTINUED TIGHTNESS. THE MESH REINFORCED MOSTLY THE GOOD TISSUE BUT HAD ALMOST COMPLETELY MISSED THE ORIGINAL DEFECT. THE ORIGINAL BULGING SENSATION FROM THE UNREPAIRED HERNIA WAS STILL PRESENT. AFTER 9 MONTHS, NUMBNESS AND PARESTHESIA BEGAN ON THE RIGHT LEG FOLLOWING FEMORAL NERVE DISTRIBUTION. THE PATIENT WAS IN CONSTANT AND DETERIORATING PAIN FOR OVER TWO YEARS. IT VARIES FROM SHARP STABBING TO PULLING AND BURNING SENSATION OVER THE FULL AREA OF THE MESH.
Patient problems: Hernia; Pain; Paresthesia
MAUDE report 22081748 ↗InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A LAPAROSCOPIC UNILATERAL RIGHT INGUINAL HERNIA REPAIR USING A MESH. THE PATIENT LATER DEVELOPED PERSISTENT RIGHT TESTICULAR AND SPERMATIC CORD PAIN RADIATING TO THE RIGHT ILIAC FOSSA, ACCOMPANIED BY EPIDIDYMAL SWELLING, SEVEN MONTHS AFTER IMPLANTATION. DESPITE NO SIGNS OF SURGICAL SITE INFECTION OR INFLAMMATION IN THE INGUINAL AREA, PHYSICAL EXAMINATION REVEALED SENSITIVITY IN THE CORD AND TESTICLE. CONSERVATIVE TREATMENT WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS WAS PRESCRIBED AND DUE TO ONGOING PAIN, THE UROLOGIST RECOMMENDED EPIDIDYMECTOMY AND PRESCRIBED MEDICINE TO ALLEVIATE NEUROPATHIC SYMPTOMS.
Patient problems: Pain; Swelling/ Edema
MAUDE report 22038171 ↗MalfunctionFeb 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ACCORDING TO THE REPORTER, POST OPERATIVELY ON A ROBOTIC LAPAROSCOPIC RIGHT INGUINAL HERNIA REPAIR WITH MESH, A BULGING WAS OBSERVED. MAGNETIC RESONANCE IMAGING (MRI) WAS CONDUCTED, AND NO ABNORMALITIES WERE FOUND. THERE WAS A POSSIBLE ALLERGIC REACTION TO A PRODUCT USED DURING THE SURGERY, AND THE PATIENT WAS UNDERGOING ALLERGY TESTING.
Patient problems: Hypersensitivity/Allergic reaction; Prolapse
MAUDE report 21351265 ↗InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A ROBOTIC TRANSABDOMINAL PREPERITONEAL (TAP) INGUINAL HERNIA REPAIR PROCEDURE USING A MESH, A RECURRENCE OF THE HERNIA OCCURRED AT THE RIGHT INGUINAL LOCATION. THIS NECESSITATED A SECOND OPERATION TO ADDRESS THE ISSUE. THE PATIENT EXPERIENCED AN EXTENDED HOSPITALIZATION, ALTHOUGH THE DURATION WAS UNSPECIFIED. IT WAS NOTED THAT AN ADDITIONAL OPERATION WILL BE PERFORMED TO CORRECT THE ISSUE.
Patient problems: Hernia
MAUDE report 21027098 ↗InjuryJul 19, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF DIAPHRAGMATIC HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, NERVE DAMAGE, INFLAMMATION, INFECTION, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.
Patient problems: Adhesion(s); Anxiety; Depression; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Inflammation; Nerve Damage; Pain; Perforation; Scar Tissue; Sleep Dysfunction; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 19782165 ↗InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD HERNIA RECURRENCE; THE PATIENT FELT THE MESH SPLIT AND HERNIA POPPING OUT AFTER COUGHING 32 WEEKS FROM THE OPERATION. ADVERSE EVENT RESULTED IN HOSPITALIZATION. IT WAS NOTED THAT THE PATIENT WAS MANAGING PAIN WITH REGULAR ANALGESIA. SYMPTOMATIC RIGHT INGUINAL HERNIA, REDUCIBLE, THAT DID NOT EXTEND INTO THE SCROTUM, LESS THAN 3CM, L2 RIGHT INDIRECT INGUINAL HERNIA. THE MESH WAS PLACED FLAT WIDELY COVERING ALL HERNIA DEFECTS ANTERIOR TO PERITONEUM ON BOTH SIDES, TUCKED BEHIND PUBIS.
Patient problems: Hernia
MAUDE report 19042779 ↗InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED WEIGHT LOSS, LOSS OF APPETITE, CHRONIC FATIGUE, NAUSEA, HEADACHES, VISION PROBLEMS, HEARING PROBLEMS, TINNITUS, DIZZINESS, EJACULATION DISORDERS, TESTICULAR ATROPHY, BLOOD DISORDERS, HYPOGAMMAGLOBULINEMIA, ABDOMINAL PAIN, DYSAUTONOMIA, DETERIORATION OF GENERAL CONDITION, ANOREXIA, DIGESTIVE DISORDERS, CONSTIPATION, DIARRHEA, SEXUAL DISTURBANCES, WEAKENED EJACULATION, PAIN, DEPRESSIVE SYNDROME, RECURRENCE, DISCOMFORT, PROSTATITIS, <(>&<)> SUICIDAL THOUGHTS. POST-OPERATIVE PATIENT TREATMENT INCLUDED ULTRASOUND, HOSPITALIZATION, MRI, <(>&<)> ANTI-DEPRESSANTS.
Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Atrophy; Bacterial Infection; Constipation; Decreased Appetite; Depression; Diarrhea; Discomfort; Dizziness; Encephalopathy; Fatigue; Headache; Hearing Impairment; Hernia; Nausea; Pain; Sexual Dysfunction; Suicidal Ideation; Tinnitus; Unspecified Blood or Lymphatic problem; Unspecified Eye / Vision Problem; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury
MAUDE report 18904886 ↗InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, 4 MONTHS POSTOPERATIVELY, OF LAPAROSCOPIC REPAIR OF THE RIGHT INGUINAL HERNIA, THE PATIENT'S MESH HAD FAILED, AND THE PATIENT WILL NEED TO REPAIR THE HERNIA AGAIN.
Patient problems: Hernia
MAUDE report 18561228 ↗InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE CLINICAL STUDY, POSTOPERATIVELY, OF LAPAROSCOPIC INGUINAL HERNIA, THERE WAS PAIN IN THE RIGHT GROIN AFTER HEAVY LIFTING. AN ULTRASOUND WAS PERFORMED, AND THERE WAS A RECURRENCE OF INGUINAL HERNIA AT THE RIGHT CAUDAL AREA FROM THE TOTALLY EXTRAPERITONEAL (TEP) MESH. THE PATIENT PLANNED FOR LICHTENSTEIN RIGHT. IT WAS NOTED THAT THE DEVICE WAS PROBABLE RELATED AND STUDY PROCEDURE WAS POSSIBLE RELATED.
Patient problems: Hernia; Pain
MAUDE report 18013900 ↗MalfunctionOct 16, 2023Degraded; Degraded
ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC RIGHT INGUINAL HERNIA PROCEDURE, AT THE TIME OF PLACEMENT AND ACCESSORY OF THE MESH ON THE WALL, THE MESH WAS PROVIDED, WHEN THE DOCTOR TRIES TO PLACE MESH IT TWIST AND DOES NOT ALLOW IT TO BE PLACED. THE WOUND WAS CLOSED WITH THE FLAP WITH SUTURE. THE MESH WAS REMOVED AND REPLACED WITH A NEW MESH. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17941757 ↗InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE LITERATURE SOURCE OF A STUDY CONDUCTED BETWEEN 2019 AND 2022, A RETROSPECTIVE STUDY EVALUATED OUTCOMES IN PATIENTS WHO UNDERWENT THE STANDARDIZED TOTAL EXTRA-PERITONEAL TECHNIQUE. IN SOME PATIENTS, A SPACEMAKER DISSECTION BALLOON WAS USED TO DISSECT THE EXTRA-PERITONEAL SPACE. DEXTILE ANATOMICAL MESH (10X15) OR A COMPETITOR MESH WAS PLACED WITHOUT FIXATION TO COVER ALL POTENTIAL HERNIA DEFECTS. THERE WERE 416 PATIENTS IN THE DEXTILE GROUP AND 540 PATIENTS IN THE COMPETITOR GROUP. POSTOPERATIVE COMPLICATIONS RELATED TO THE MESH INCLUDED SEROMA, HEMATOMA, PAIN, AND HERNIA RECURRENCE. COMPLICATIONS RELATED TO SPACEMAKER INCLUDED WOUND INFECTION AND DELAYED WOUND HEALING. RECURRENCES WERE DUE TO EITHER A LIPOMA OR A TRUE RECURRENCE, REQUIRING EITHER SURGICAL REPAIR OR CONSERVATIVE TREATMENT. PAIN WAS MANAGED WITH ANALGESICS, LIDOCAINE INJECTIONS, OR PULSED RADIOFREQUENCY ABLATION. ANTIBIOTICS WERE NECESSARY FOR INFECTION, AND PROLONGED HOSPITALIZATION WAS REPORTED.
Patient problems: Hematoma; Hernia; Pain; Seroma
MAUDE report 17906591 ↗MalfunctionDec 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC INGUINAL HERNIA PROCEDURE, WHILE THE SURGEON WAS UNFOLDING MESH WITHIN THE INGUINAL SPACE POST TROCAR INSERTION AND PRIOR TO PLACEMENT, THE SURGEON VISUALLY NOTED THAT SOMETHING HAD FALLEN OUT. THE SURGEON ALSO RETRIEVED THE ITEM TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15904947 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.