ProGripRecalls & reported problems across all models
Sofradim Production · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,194
- Deaths reported
- 16
- Injuries reported
- 2,970
- Recalls
- 0
We found 24 models of ProGrip by Sofradim Production in the FDA's device registry (GUDID). Together they are named in 3,194 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2016 and Sep 17, 2026 — classified as 16 deaths, 2,970 injuries, 208 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (1,310 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ProGrip problems
Device problems
- Adverse Event Without Identified Device or Use Problem2,983
- Mechanics Altered1,310
- Migration or Expulsion of Device816
- Insufficient Device Problem Information273
- Patient Device Interaction Problem262
- Material Split, Cut or Torn197
- Material Integrity Problem129
- Material Deformation95
Patient problems
- Pain2,406
- Hernia2,367
- Unspecified Tissue Injury2,215
- Adhesion(s)1,569
- Emotional Changes1,400
- Injury1,358
- Scar Tissue1,253
- Inflammation1,055
ProGrip models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ProGrip LPG1510Mesh, surgical, polymeric2 deaths616 reports
- ProGrip TEM1509GMesh, surgical, polymeric3 deaths471 reports
- ProGrip TEM1208GRMesh, surgical, polymeric406 reports
- ProGrip TEM1208GLMesh, surgical, polymeric3 deaths352 reports
- ProGrip LPG1510ARMesh, surgical, polymeric3 deaths300 reports
- ProGrip TEM1515GMesh, surgical, polymeric288 reports
- ProGrip LPG1510ALMesh, surgical, polymeric1 death219 reports
- ProGrip TEM3015GMesh, surgical, polymeric1 death159 reports
- ProGrip TEM2015GMesh, surgical, polymeric66 reports
- ProGrip LPG1510X2Mesh, surgical, polymeric60 reports
- ProGrip TEM1409GRMesh, surgical, polymeric58 reports
- ProGrip LPG1612Mesh, surgical, polymeric57 reports
- ProGrip TEM1409GLMesh, surgical, polymeric48 reports
- ProGrip LPG1612ARMesh, surgical, polymeric28 reports
- ProGrip LPG1612ALMesh, surgical, polymeric19 reports
- ProGrip LPG1614Mesh, surgical, polymeric12 reports
- ProGrip PP1208DLMesh, surgical, polymeric1 death11 reports
- ProGrip LPG1510AK2Mesh, surgical, polymeric10 reports
- ProGrip PP1208DRMesh, surgical, polymeric1 death5 reports
- ProGrip PP1509GMesh, surgical, polymeric3 reports
- ProGrip LPG1309ALMesh, surgical, polymeric3 reports
- ProGrip LPG1309ARMesh, surgical, polymeric1 report
- ProGrip PP3030GMesh, surgical, polymeric1 death1 report
- ProGrip ADG3020Mesh, surgical, polymeric1 report
Recent ProGrip adverse event reports
The 15 most recent reports across all models, 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 ↗DeathAug 20, 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, death. Post-operative patient treatment included revision surgery. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.
Patient problems: Adhesion(s); Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury
MAUDE report 50356230 ↗MalfunctionAug 19, 2026Break; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333536 ↗MalfunctionAug 12, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Blurred Vision; Discomfort; Pain
MAUDE report 50218628 ↗InjuryAug 11, 2026Mechanics Altered; Adverse Event Without Identified Device or Use Problem
The patient¿s attorney alleged a deficiency against the device. The product was used for a laparoscopic therapeutic treatment of a bilateral inguinal hernia. It was reported that after implant, the patient experienced abdominal pain, recurrent hernia, rectus diastasis, defective mesh, pain, suffering, emotional distress, disability, impairment, and loss of enjoyment of life. Post-operative patient treatment included resection of skin and subcutaneous tissue and mesh removal.
Patient problems: Abdominal Pain; Distress; Emotional Changes; Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury
MAUDE report 50216870 ↗MalfunctionAug 11, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202258 ↗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 31, 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 inguinal hernia. It was reported that after the implant, the patient experienced inflammatory mass, lower abdominal wall weakness, pain, inflammation, allergic reaction, adhesions, neuroma, <(>&<)> numbness. Post-operative patient treatment included mesh removal, removal of mass, resection of ilioinguinal nerve, reinforcement of lower abdominal wall, <(>&<)> medication.
Patient problems: Adhesion(s); Hypersensitivity/Allergic reaction; Inflammation; Muscle Weakness/Atrophy; Nodule; Numbness; Pain; Unspecified Tissue Injury
MAUDE report 50094206 ↗InjuryJul 30, 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 an inguinal hernia. It was reported that after implant, the patient experienced meshoma, pain, recurrence, inflammation and fold in mesh. Post-operative patient treatment included medication and resection of meshoma.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Inflammation; Pain; Unspecified Tissue Injury
MAUDE report 50089630 ↗InjuryJul 29, 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 inguinal hernia. It was reported that after the implant, the patient experienced testicular mass, testicular pain, hematuria, hernia recurrence, adhesions, pain, <(>&<)> bleeding. Post-operative patient treatment included hernia repair with mesh, diagnostic lap, lysis of adhesions, orchiectomy, <(>&<)> medication.
Patient problems: Adhesion(s); Hematuria; Hemorrhage/Blood Loss/Bleeding; Hernia; Nodule; Pain; Unspecified Tissue Injury
MAUDE report 50077118 ↗InjuryJul 28, 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, inflammation.
Patient problems: Hernia; Inflammation; Pain; Unspecified Tissue Injury
MAUDE report 50060149 ↗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, adhesions, nerve damage. Post-operative patient treatment included medication.
Patient problems: Adhesion(s); Hernia; Nerve Damage; Pain; Unspecified Tissue Injury
MAUDE report 50020119 ↗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 ↗
Other Sofradim Production products
All Sofradim Production devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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