ProGrip TEM3015GRecalls & reported problems
Sofradim Production · Self-Gripping Polyester Mesh,Polyester with Polylactic Acid Grips · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ProGrip self-gripping hernia mesh is used to repair hernias. Reports mostly describe hernias returning, pain, and mesh tears, holes or migration, and many say a patient's attorney alleged a device deficiency. The 159 reports include 1 death and 155 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
- 159
- Deaths reported
- 1
- Injuries reported
- 155
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 10884521177741), received between Aug 2, 2017 and Jun 4, 2026 — classified as 1 death, 155 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (35 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 Problem143
- Mechanics Altered35
- Migration or Expulsion of Device28
- Material Split, Cut or Torn19
- Patient Device Interaction Problem18
- Insufficient Device Problem Information11
- Material Integrity Problem8
- Degraded5
Patient problems
- Hernia113
- Pain108
- Unspecified Tissue Injury107
- Adhesion(s)85
- Injury65
- Unspecified Infection49
- Inflammation47
- Emotional Changes45
Recent adverse event reports
The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, SUFFERING, SEROMA, NONHEALING SURGICAL WOUND, ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, UNILATERAL TRUNCAL COMPONENT RELEASE, MESH REVISION AND INCISION AND DRAINAGE.
Patient problems: Abdominal Pain; Hernia; Impaired Healing; Pain; Seroma; Unspecified Tissue Injury
MAUDE report 25394723 ↗MalfunctionMay 14, 2026Degraded; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING ABDOMINAL WALL HERNIA REPAIR USING A PRE-PERITONEAL APPROACH, AT THE TIME OF INSTALLATION, HOLES AND FRAGILE AREAS WERE OBSERVED IN THE MIDDLE OF THE MESH. ANOTHER MESH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 25170184 ↗InjuryApr 17, 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 MESH FAILURE, PAIN, LOSS OF ENJOYMENT OF LIFE, EMOTIONAL CHANGES, AND DISABILITY.
Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 24912716 ↗InjuryApr 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, EMOTIONAL CHANGES, DISCOMFORT, DISABILITY, LOSS OF ENJOYMENT OF LIFE.
Patient problems: Discomfort; Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 24820521 ↗InjuryApr 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, EMOTIONAL CHANGES, DISCOMFORT, DISABILITY, LOSS OF ENJOYMENT OF LIFE.
Patient problems: Discomfort; Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 24820512 ↗InjuryApr 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 A FLANK HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, SUFFERING.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24769599 ↗InjuryMar 30, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MUSCLE SPASMS, PAIN, ABDOMINAL PAIN, HERNIA RECURRENCE, SMALL DEFECT IN MESH, INTRAABDOMINAL FAT, FALCIFORM LIGAMENT PROTRUDED THROUGH DEFECT DIRECTLY INTO MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED PAIN MEDICATION, JP DRAINS LEFT INDWELLING, SUTURE REMOVED, PRIMARY HERNIA REPAIR, MESH REVISION.
Patient problems: Abdominal Pain; Cramp(s) /Muscle Spasm(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24716161 ↗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 INCISIONAL 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 24119219 ↗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 INCISIONAL 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 24119209 ↗InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, INFLAMMATION, ALLERGIC REACTION, ADHESIONS, PERFORATION, ABSCESS, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, SMALL BOWEL RESECTION.
Patient problems: Abscess; Adhesion(s); Discomfort; Hypersensitivity/Allergic reaction; Inflammation; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 23649308 ↗InjuryOct 24, 2025Adverse 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED 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 23379787 ↗InjuryJun 24, 2025Adverse 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 22321280 ↗InjuryJun 20, 2025Adverse 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, MEDICATION, AND POSTERIOR COMPONENTS PARTS SEPARATION.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 22299631 ↗InjuryJun 6, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SEROMA, BOWEL OBSTRUCTION, HEMATOMA, SCARRING, ADHESIONS, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Adhesion(s); Emotional Changes; Hematoma; Hernia; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury
MAUDE report 22159626 ↗InjuryMar 25, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, PAIN, RECURRENCE, ADHESIONS, PARTIAL THICKNESS BURN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, ORAL PAIN MEDICATION, IV FLUIDS, REMOVAL OF JP DRAINS, REMOVAL OF WOUND VAC, WOUND CARE, ANTIBIOTIC OINTMENT.
Patient problems: Adhesion(s); Burn(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 21691087 ↗InjuryFeb 20, 2025Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Integrity 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Adhesion(s); Distress; Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury
MAUDE report 21425930 ↗InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, A TREATMENT OF RECTOCELE AND ELYTROCELE VAGINALLY WAS DONE. PLACEMENT OF A PLATE ATTACHED TO THE FOUR CARDINAL CORNERS AND REINFORCING THE VAGINAL WALL. LONGITUDINAL COLPOTOMY AND INCISION OF THE VAGINAL FORK WERE ALSO DONE. IN 2016, THERE WAS A RECURRENCE OF EVENTRATION OF THE ABDOMINAL WALL OPERATED BY LAPAROSCOPIC APPROACH. IT WAS NOTED THAT THE EXPLORATION FINDS A LARGE AREA OF SUPRA AND PERIUMBILICAL WEAKNESS WITH AREAS OF DISINSERTION OF THE INITIAL PROSTHESIS. SUTURING AND AN INSERTION OF A PROSTHESIS CUT WITH ADAPTED TO THE SIZE OF THE EVENTRATION WERE DONE. IN 2019, THE PATIENT EXPERIENCED SIGNIFICANT PAIN IN LOWER LUMBAR AND PELVIC HEADACHES CORRESPONDING TO HEADACHES ON PROSTHETIC MATERIAL PLACED VAGINALLY IN 2015. PROMONTOFIXATION WAS DONE. IN 2021, THE PATIENT'S CONDITION HAS DETERIORATED A LOT. PELVIC AND LOWER BACK PAIN AND BURNING WERE ALMOST PERMANENT AND TREATED WITH A TRAMADOL TABLET EVERY 12 HOURS. A REPEATED URINARY TRACT INFECTIONS (UTI), EVEN TWO PER MONTH DESPITE ONE SACHET OF MONURIL PER WEEK. IN ADDITION, SINCE (B)(6) 2024 FUNGAL INFECTIONS EVERY MONTH TREATED WITH FLUCONAZOLE. THE PATIENT HAS DIFFICULTY WALKING WITH STIFF JOINTS
Patient problems: Fungal Infection; Hernia; Pain; Pelvic Inflammatory Disease; Urinary Tract Infection
MAUDE report 21368075 ↗InjuryOct 1, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CYSTIC STRUCTURE, HEMATOMA, SEROMA, HERNIA RECURRENCE, FLUID COLLECTION, S. ENTERITIDIS, SWELLING, FIBROSIS, PAIN, FEVER, NAUSEA, VOMITING, INFECTED SEROMA, CELLULITIS, RED & INFLAMED SKIN, PUS, NECROTIC TISSUE, ABSCESS, & OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED ULTRASOUND, CT SCAN, SEROMA DRAINAGE IN OFFICE, MULTIPLE INCISION & DRAINAGES OF SEROMA, EXCISION OF SEROMA CAVITY & EVACUATION, USE OF DRAINS, MULTIPLE HOSPITALIZATIONS, IV ANTIBIOTICS, NECROTIC TISSUE REMOVED, & INCISION & DRAINAGE OF ABSCESS.
Patient problems: Abscess; Ascites; Bacterial Infection; Cellulitis; Cyst(s); Erythema; Fever; Fibrosis; Hematoma; Hernia; Impaired Healing; Inflammation; Nausea; Necrosis; Pain; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting
MAUDE report 20346373 ↗InjurySep 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 LEFT LUMBAR HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 20218810 ↗InjurySep 11, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL AND PHYSICAL PAIN, PHYSICAL DEFORMITY, MESH FAILED, SUFFERING, MENTAL ANGUISH, SCARRING, DISFIGUREMENT, HERNIA RECURRENCE, SEROMA, ADHESIONS, ABDOMINAL PAIN, LIMITED MOBILITY, SMALL BOWEL ENTEROTOMY, DISCOMFORT, AND BOWEL INCARCERATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, HERNIA REPAIRED WITH MESH, REVISION SURGERY, MEDICATION.
Patient problems: Abdominal Pain; Adhesion(s); Deformity/ Disfigurement; Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury
MAUDE report 20197157 ↗InjurySep 3, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, AND RECURRENCE.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 20129429 ↗InjuryAug 5, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, CORD LIPOMA, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, INTERVENTION SURGERY, ILIOINGUINAL BLOCK, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.
Patient problems: Emotional Changes; Hernia; Nodule; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 19912685 ↗InjuryJul 8, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED DRAINAGE FROM WOUND, WOUND INFECTION, NECROSIS, FISTULA, INFLAMMATORY RIND, SCAR TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, INCISION, DRAINAGE OF ABDOMINAL WALL WOUND, DEBRIDEMENT OF SKIN, SOFT TISSUE, COMPLEX WOUND CLOSURE OF ABDOMINAL WALL, REMOVAL OF SUTURE, ABDOMINAL WALL WOUND CLOSURE.
Patient problems: Fistula; Fluid Discharge; Impaired Healing; Inflammation; Necrosis; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 19693518 ↗InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction 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 UNINCORPORATED MESH, HERNIA RECURRENCE, ADHESIONS, FIBROADIPOSE TISSUE ADHERENT TO MESH, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, ABDOMINAL WALL RECONSTRUCTION, MEDICATION.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 18883720 ↗InjuryFeb 13, 2024Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, CRUMPLED MESH, LOSS OF APPETITE, PAIN, INFECTION, RECURRENCE, HEMATOMA, ADHESIONS, OBSTRUCTION, SMALL SEROSAL TEAR IN COLON. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, TAP BLOCK.
Patient problems: Adhesion(s); Decreased Appetite; Hematoma; Hernia; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 18696806 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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