ProGrip LPG1612ARRecalls & reported problems
Sofradim Production · Laparoscopic Self-Fixating Mesh, Right Anatomical · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Sofradim ProGrip self-fixating surgical mesh is used to repair groin and other hernias. The 29 reports mostly describe mesh tearing or splitting at its seam or suture line while being unfurled in the operating room, mesh shifting or moving after implantation, and patients who later had pain, adhesions, returning hernia, or bowel tangled in the mesh, with several needing revision surgery. The reports describe 21 injuries and no deaths. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10884521513228), received between Mar 22, 2018 and Feb 23, 2026 — classified as 21 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (10 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 Problem22
- Mechanics Altered10
- Migration or Expulsion of Device8
- Material Split, Cut or Torn5
- Insufficient Device Problem Information2
- Device Misassembled During Manufacturing /Shipping1
- Patient Device Interaction Problem1
- Torn Material1
Patient problems
- Pain18
- Unspecified Tissue Injury17
- Hernia16
- Adhesion(s)11
- Emotional Changes10
- Scar Tissue9
- Inflammation8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, ROUND LIGAMENT LIPOMA, MESH MIGRATION, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, DIAGNOSTIC LAP, REPAIR OF HERNIA, REMOVAL OF ROUND LIGAMENT LIPOMA.
Patient problems: Distress; Hernia; Nodule; Unspecified Tissue Injury
MAUDE report 24416590 ↗InjuryNov 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, FLATUS, ABDOMINAL PAIN, HEMORRHOIDS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.
Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Flatus; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 23607624 ↗InjuryNov 17, 2025Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, INCARCERATED HERNIA, MESH MIGRATION, CONSTIPATION, CRAMPS, INTESTINE STRANGULATION, INTESTINE TANGLED IN MESH AND TESTICULAR PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY AND MEDICATION.
Patient problems: Adhesion(s); Constipation; Cramp(s) /Muscle Spasm(s); Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury
MAUDE report 23575916 ↗MalfunctionNov 18, 2024Device Misassembled During Manufacturing /Shipping; Adverse Event Without Identified Device or Use Problem; Device Misassembled During Manufacturing /Shipping; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A ROBOTIC INGUINAL HERNIA REPAIR, WHEN THE MESH WAS INSERTED, UNROLLED, AND IT WAS A WRONG-SIDE MESH. IT WAS A LEFT SIZE IN A RIGHT SIZE BOX. TO RESOLVE THE ISSUE, THE MESH WAS TAKEN OUT AND ANOTHER CORRECT-SIDED PIECE WAS PUT IN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20708402 ↗InjurySep 17, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FOLDED MESH, RECURRENCE, PAIN, ADHESIONS.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 20242032 ↗MalfunctionJul 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING THE ROBOTIC LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE MESH STARTED TO TEAR AT THE SEAM AFTER UNFOLDING IT TO PLACE IT IN THE BODY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19735876 ↗InjuryJun 14, 2024Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 INGUINAL AND UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, MESH MIGRATION, RECURRENCE, INFLAMMATION, INFECTION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 19539283 ↗MalfunctionSep 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING ROBOT-ASSISTED INGUINAL HERNIA SURGERY, AT INSTALLATION, THE ADHESIVE BACKING ON THE PLATE TORE. ANOTHER MESH (DIFFERENT MODEL) WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17840630 ↗InjuryAug 14, 2023Mechanics 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, HYDROCELE, MASS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Erectile Dysfunction; Hernia; Inflammation; Nodule; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 17543162 ↗InjuryJun 19, 2023Mechanics 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, ADHESIONS, RECURRENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, TAKE DOWN OF ADHESIONS.
Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 17156861 ↗MalfunctionApr 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE MESH WAS TORN RIGHT OF THE PACKAGE. THE DEVICE COULD NOT BE USED FOR THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 16834314 ↗InjuryMar 24, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, FAILURE OF MESH, RECURRENCE, PAIN, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, HERNIA REPAIR WITH NEW MESH.
Patient problems: Discomfort; Distress; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 16611645 ↗InjuryFeb 8, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, PAIN, DISABILITY, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 16330107 ↗MalfunctionAug 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR-TRANSABDOMINAL PREPERITONEAL, AFTER OPENING THE PACKAGE, BEFORE USING IT INSIDE THE PATIENT, THE SURGEON COULD NOT USED THE MESH SINCE IT WAS DAMAGED. A NEW MESH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15213436 ↗InjuryMar 24, 2022Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, PAIN, INJURY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Abdominal Distention; Emotional Changes; Hernia; Nodule; Pain; Unspecified Tissue Injury
MAUDE report 13875871 ↗InjuryMar 24, 2022Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, PAIN, INJURY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Necrosis; Nodule; Pain; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 13874524 ↗InjuryMar 9, 2022Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, PAIN, TESTICULAR DISCOMFORT, ADHESIONS, MESH INGROWTH INTO WALL, INFLAMMATION, LEFT VARICOCELE, LOW SPERM COUNT, MALE PATTERN INFERTILITY, SCARRING, AND MENTAL ANGUISH. POST-OPERATIVE PATIENT TREATMENT INCLUDED PHYSICAL THERAPY, ANTI-INFLAMMATORY MEDICATION, MARCAINE AND DEXAMETHASONE INJECTIONS, DIAGNOSTIC BLOCK BY INJECTING BUPIVACAINE, EXCISION OF MESH, HERNIA REPAIR, ADHESIOLYSIS, SPERMATIC CORDS FREED, MRI, AND NEUROLYSIS.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Erosion; Foreign Body Reaction; Hernia; Inflammation; Pain; Perforation; Scar Tissue; Unspecified Tissue Injury
MAUDE report 13710940 ↗InjuryJul 15, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, MESH MIGRATION, CHRONIC PAIN, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, HERNIA RECURRENCE, SYMMETRIC LEFT-SIDED PARASYMPHYSEAL REACTIVE EDEMA, BULGING MASS, INGUINODYNIA, NUMBNESS, TENDERNESS, ACHINESS, MESH CLAMSHELLED, ADHESIONS, TESTICLES SWOLLEN, BLOATED, AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, PARTIAL REMOVAL OF MESH, AND NERVE BLOCKS.
Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Inflammation; Nerve Damage; Nodule; Numbness; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury
MAUDE report 12178648 ↗InjuryJul 2, 2021Migration 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, HERNIA RECURRENCE, CHRONIC GROIN PAIN, AND ADHESIONS.
Patient problems: Adhesion(s); Constipation; Fistula; Hernia; Inflammation; Nodule; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 12112400 ↗InjuryJun 18, 2021Adverse 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, CORD LIPOMA, BULGE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED NERVE BLOCK USING 0.25% BUPIVACAINE/DEPO-MEDROL/FLUOROSCOPIC GUIDANCE, REMOVAL OF BALL OF FAT FO UND IN THE DIRECT HERNIA SPACE, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH AND INCORPORATING PREVIOUS MESH.
Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 12025443 ↗InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, FOUR MONTHS FOLLOWING A LAPAROSCOPIC RIGHT INGUINAL HERNIA REPAIR WITH MESH, THE PATIENT EXPERIENCED CONSTANT PAIN ON THE GROIN, LEG AND LOWER ABDOMEN. IT WAS STATED THAT THE PATIENT STRUGGLED WITH CONSTANT NAGGING PAIN AND BURNING SENSATION AND COULD NOT SIT COMFORTABLY. THE PATIENT CAN ONLY SLEEP ON ONE SIDE AND HAD DISRUPTED SLEEP SEVERAL TIMES EVERY NIGHT CAUSING THE PATIENT TO BE TIRED AND LETHARGIC DURING THE DAY.
Patient problems: Pain
MAUDE report 11913912 ↗MalfunctionDec 23, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A ROBOTIC RIGHT HERNIORRHAPHY INGUINAL WITH MESH PROCEDURE, THE SURGEON PUSHED THE MESH TROUGH THE TROCAR AND INTO THE PATIENT'S ABDOMEN. THE SURGEON THEN BEGAN TO UNFOLD THE MESH AND A TEAR WAS NOTICED AT THE SEAM OF THE MESH. A NEW MESH WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11065645 ↗InjuryOct 19, 2020Adverse 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, HYDROCELE, ADHESIONS, SCARRING, SPERMATIC CORD INJURED, NERVE DAMAGE, SCAR TISSUE, TESTICLE ISCHEMIA, AND INGUINAL NERVE PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED LEFT ORCHIECTOMY, REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND EXCISION OF LEFT HYDROCELE.
Patient problems: Adhesion(s); Hernia; Injury; Ischemia; Nerve Damage; No Code Available; Pain; Scar Tissue; Scarring
MAUDE report 10701976 ↗InjuryAug 24, 2020Adverse 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 A HYDROCELE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HYDROCELECTOMY.
Patient problems: Injury; No Code Available
MAUDE report 10445333 ↗InjuryFeb 4, 2020Mechanics 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, CHRONIC PAIN, RECURRENCE, INFLAMMATION, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, SCARRING, AND SWELLING ABDOMEN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.
Patient problems: Emotional Changes; Hernia; Inflammation; Injury; Pain; Scar Tissue; Swelling; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 9668225 ↗
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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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