ProGrip LPG1510Recalls & reported problems
Sofradim Production · Laparoscopic Self-Fixating Mesh Polyester with Polylactic Acid Grips and Collagen Film · Class 2 · Implant
Quick summary
This is a Sofradim ProGrip laparoscopic hernia mesh. The 614 reports mostly describe pain, hernia recurrence, and adhesions after implantation, with some describing mesh migrating or failing. The reports mention 2 deaths and 585 injuries. Several reports say an attorney alleged a problem with the mesh. 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
- 616
- Deaths reported
- 2
- Injuries reported
- 587
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 616 adverse event reports that list this exact device (DI 10884521513136), received between Sep 19, 2017 and Sep 17, 2026 — classified as 2 deaths, 587 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (297 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 Problem592
- Mechanics Altered297
- Migration or Expulsion of Device194
- Insufficient Device Problem Information72
- Patient Device Interaction Problem48
- Material Integrity Problem29
- Material Deformation18
- Material Split, Cut or Torn11
Patient problems
- Pain494
- Hernia476
- Unspecified Tissue Injury451
- Adhesion(s)329
- Emotional Changes324
- Scar Tissue259
- Injury241
- Inflammation217
Recent adverse event reports
The 25 most recent of 616 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Migration or Expulsion of Device; Adverse 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 a laparoscopic therapeutic treatment of an bilateral inguinal hernia. It was reported that after implant, the patient experienced pain, mental pain, scarring, permanent impairment, loss of enjoyment of life, defective mesh, inflammation, mesh migration, failure of mesh, adhesions, abdominal pain, tenderness, phleboliths (calcified thrombi), crampy abdominal pain, nausea, entrapped nerve syndrome, low back pain, hip pain, and muscle spasm. Post-operative patient treatment included revision surgery, laparoscopy with lysis of adhesions, mesh intervention surgery, X-ray, TAP block, ultrasound, and fluoroscopy. Concomitant Device: Absorbatac stapler.
Patient problems: Abdominal Cramps; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Back pain; Cramp(s) /Muscle Spasm(s); Discomfort; Emotional Changes; Inflammation; Nausea; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 50806088 ↗InjuryAug 4, 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 a hernia. It was reported that after implant, the patient experienced emotional distress, recurrence, pain, suffering, mesh failure, <(>&<)> scrotal swelling. Post-operative patient treatment included revision surgery, hernia repair with new mesh, <(>&<)> hernia repair.
Patient problems: Distress; Hernia; Pain; Swelling/ Edema; Unspecified Tissue Injury
MAUDE report 50131143 ↗InjuryJul 27, 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 an inguinal hernia. It was reported that after implant, the patient experienced pain, recurrence, hernia building out, difficulty urinating. Post-operative patient treatment included hernia repair with new mesh and medication.
Patient problems: Abdominal Distention; Hernia; Pain; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury
MAUDE report 50008840 ↗InjuryJul 7, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FREQUENT URINATION, DEFECTIVE MESH, FAILURE OF MESH, NERVE DAMAGE, RECURRENCE, CORD LIPOMA, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, LEFT GROIN EXPLORATION, REVISION SURGERY, REMOVAL OF MESH, EXCISION OF LIPOMA, LITIGATION OF LEFT INGUINAL NERVE.
Patient problems: Emotional Changes; Hernia; Nerve Damage; Nodule; Pain; Scar Tissue; Unspecified Tissue Injury; Urinary Frequency / Polyuria
MAUDE report 25734901 ↗InjuryJun 29, 2026Migration or Expulsion of Device; 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 IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, PAIN, RECURRENCE, ADHESIONS, EMOTIONAL CHANGES. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.
Patient problems: Adhesion(s); Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25658525 ↗InjuryJun 9, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, ENTEROTOMY, AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, REPAIR OF ENTEROTOMY, MESH REVISION, PRIMARY RECURRENT INCISIONAL HERNIA REPAIR.
Patient problems: Adhesion(s); Distress; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25445527 ↗InjuryJun 8, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING.
Patient problems: Pain; Unspecified Tissue Injury
MAUDE report 25430456 ↗InjuryJun 2, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, EMOTIONAL DISTRESS, ANXIETY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.
Patient problems: Anxiety; Distress; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25363904 ↗InjuryMay 27, 2026Migration or Expulsion of Device; Adverse 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MESH MIGRATION, ADHESIONS, RECURRENCE, PAIN, NERVE DAMAGE, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.
Patient problems: Adhesion(s); Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury
MAUDE report 25311338 ↗InjuryMay 6, 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 VENTRAL AND INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION AND HERNIA REPAIR WITH NEW MESH.
Patient problems: Distress; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25095934 ↗InjuryMay 1, 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 A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 25057877 ↗InjuryMay 1, 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 A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 25057796 ↗InjuryApr 30, 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 AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Distress; Pain; Unspecified Tissue Injury
MAUDE report 25048841 ↗InjuryApr 27, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Distress; Unspecified Tissue Injury
MAUDE report 25004162 ↗InjuryApr 13, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 24860984 ↗InjuryApr 13, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 24860875 ↗InjuryApr 7, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24807778 ↗InjuryApr 3, 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, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 24781357 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER IMPLANTATION OF THE MESH, SEVERE PAIN OCCURRED AT THE IMPLANT SITE, BACK, AND LEGS UPON WAKING AFTER THE OPERATION. THE INDIVIDUAL EXPERIENCED DIFFICULTY STANDING, SITTING, AND WALKING, AS WELL AS ELECTRIC SHOCKS IN THE LEGS. PERSISTENT INFLAMMATION, NERVE DAMAGE, AND MAJOR FUNCTIONAL DISORDERS WERE NOTED. CHRONIC DISABLING PAIN IN THE PELVIS AND A BURNING SENSATION IN THE PROSTHESIS AREA WERE DESCRIBED, ALONG WITH ADHESIONS OF INTERNAL ORGANS CAUSING UNBEARABLE PAIN. ADDITIONAL SYMPTOMS INCLUDED DIFFICULTY SPEAKING AND LOSS OF VOICE AFTER MEALS, COMPRESSION OF THE DIAPHRAGM, AND TINNITUS. THE INDIVIDUAL REPORTED AN INABILITY TO WORK SINCE THE OPERATION, INABILITY TO WALK OR SIT FOR MORE THAN 10 TO 15 MINUTES WITHOUT SEVERE PAIN AND ELECTRIC SHOCKS, INABILITY TO SHOP OR MAKE CAR JOURNEYS, AND A PAINFUL LYING POSITION WITH TIGHTNESS AND MUSCLE SPASMS THAT DISTURBED SLEEP. SLEEP DISTURBANCE DUE TO MUSCLE SPASMS AND TIGHTNESS WAS ALSO REPORTED. DISABILITY WAS RECOGNIZED (RQTH RECOGNITION SINCE JUNE 2024), AND THERE WAS A LOSS OF SOCIAL LIFE AND INABILITY TO GO ON FAMILY OUTINGS. CHRONIC PAIN REQUIRED FOLLOW-UP AT A CHRONIC PAIN CENTER, AND PSYCHOLOGICAL FOLL
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Discomfort; Hiccups; Inflammation; Nerve Damage; Pain; Sleep Dysfunction; Tinnitus; Voice alteration
MAUDE report 24750376 ↗MalfunctionMar 24, 2026Difficult or Delayed Positioning
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA TOTALLY EXTRAPERITONEAL (TEP) PROCEDURE, WHEN THE MESH WAS APPLIED, THE MESH DID NOT ADHERE TO TISSUE AS EXPECTED, AND THE SURGEON NOTED THAT THE BLUE PART OF THE MESH KEPT UNSTICKING. THE MESH WAS NOT CUT PRIOR TO IMPLANTATION, WAS NOT IMPLANTED IN A CONTAMINATED FIELD, AND APPEARED AS EXPECTED IN COLOR, TEXTURE, AND MOISTURE. THE WOUND WAS CLOSED WITH SUTURE AND GLUE, AND THE MESH WAS SELF-FIXATING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672323 ↗MalfunctionMar 24, 2026Difficult or Delayed Positioning
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA TOTALLY EXTRAPERITONEAL (TEP) PROCEDURE, WHEN THE MESH WAS APPLIED, THE MESH DID NOT ADHERE TO TISSUE AS EXPECTED, AND THE SURGEON NOTED THAT THE BLUE PART OF THE MESH KEPT UNSTICKING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672311 ↗InjuryMar 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 A LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.
Patient problems: Adhesion(s); Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 24651243 ↗InjuryMar 16, 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 RECURRENCE AND PAIN.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24607392 ↗MalfunctionMar 3, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A LAPAROSCOPIC INGUINAL HERNIA REPAIR IN (B)(6) 2023. A MESH WAS IMPLANTED DURING THE PROCEDURE. AFTER SURGERY, THE PATIENT EXPERIENCED RECURRING PAIN IN THE GROIN. THE DOCTOR SUSPECTED THAT THE CAUSE WAS EITHER A REJECTION REACTION TO THE IMPLANT OR ISSUES WITH THE SCAR TISSUE.
Patient problems: Pain
MAUDE report 24499761 ↗MalfunctionMar 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PAIN OCCURRED FOLLOWING THE PLACEMENT OF TWO PROSTHESES TO TREAT INGUINAL HERNIAS. THE PATIENT PRESENTED WITH A LEFT INGUINAL HERNIA WITH PAIN RADIATING TO THE TESTICULAR AREA, AND A NARROW-NECKED HERNIA THAT WAS PAINFUL DURING EXERTION, INTERFERING WITH SPORTS ACTIVITIES. LAPAROSCOPIC REPAIR OF THE LEFT INGUINAL HERNIA WAS PERFORMED WITH PLACEMENT OF A PROSTHETIC REINFORCEMENT. SUBSEQUENTLY, A DIRECT MEDIAL RECURRENCE OF THE LEFT INGUINAL HERNIA WAS CONFIRMED BY ULTRASOUND, AND OPEN REPAIR OF THE RECURRENT HERNIA WAS PERFORMED WITH PROSTHETIC REINFORCEMENT. THE PATIENT EXPERIENCED VARIOUS PAINS SEVERAL TIMES A DAY IN THE PUBIC AND TESTICULAR AREAS, WITH PAIN WORSENED BY SITTING AND DURING SPORTS ACTIVITIES.
Patient problems: Hernia; Pain
MAUDE report 24497257 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.