3DMAX 0115311Recalls & reported problems

Summary

The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 00801741030734), received between Mar 3, 2016 and Aug 25, 2026 — classified as 187 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Defective Device” (129 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 209 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Patient-Device Incompatibility

  Per information provided: (b)(6) 2010 - Patient was diagnosed with incarcerated left inguinal hernia thereby underwent laparoscopic repair with implant of 3DMax Mesh (Device 1 and Device 2 - Left). Per operative notes, "An incision was made in the left lateral abdomen. The left inguinal hernia sacs were dissected out. A 3DMax Mesh (Device 1) was placed into the peritoneal cavity and secured it with sutures. Another 3Dmax Mesh (Device 2) was placed anteriorly along the upper of the (Device 1) with good coverage and secured it with sutures." (b)(6) 2013 - Patient was diagnosed with recurrent left inguinal hernia, hematoma thereby underwent open repair with implant of synthetic mesh. Per operative notes, "A curvilinear incision was made along the skin lines in the left lower quadrant just over the inguinal ligament. The hernia sac was dissected out. There was a large bulky hematoma which was removed. It speared that the new defect was posterior to the previously placed 3DMax Mesh (Device 1 and Device 2). A synthetic mesh was placed into the left groin and secured it with sutures."

  Patient problems: Hematoma; Hernia

  MAUDE report 50431561 ↗
• InjuryJul 30, 2026Migration

  Per information provided:On (b)(6) 2022- Patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with implant of 3DMax Meshes (Device 1 and 2). Per op notes, "A large indirect hernia sac was identified in right inguinal region and dissected. A 3DMax Mesh (Device 1) was then placed and sutured. There was a direct hernia and an indirect sac in the left inguinal region and was dissected. A 3DMax Mesh (Device 2) was then placed and sutured." On (b)(6) 2022- Patient was diagnosed with infected mesh bilateral groins, thereby underwent laparoscopic repair with explant of 3DMax Meshes (Device 1 and 2). Per op notes, "In the left inguinal region, Adhesions from the anterior abdominal wall was identified and the 3DMax Mesh (Device 2) was found free floating and was excised. In right inguinal region, most part of 3DMax Mesh (Device 2) was found to be inflamed and infected. Abscess through rectus muscle was also noted and the 3DMax Mesh (Device 1) was completely excised."

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50083001 ↗
• InjuryJun 10, 2026Patient-Device Incompatibility

  AS PER ANSM N° R2615162 (IN SUMMARY): IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT INGUINAL SCROTAL HERNIA REPAIR WITH THE IMPLANT OF 3DMAX MESH ON (B)(6) 2018. INITIALLY, A VARICOCELE WAS SUSPECTED DUE TO A PALPABLE MASS IN THE LEFT TESTICLE. DURING THE FIRST UROLOGY CONSULTATION, NO CLINICAL DIAGNOSIS OF A HERNIA HAD BEEN MADE. HOWEVER, A SUBSEQUENT ULTRASOUND SCAN REVEALED AN IMAGE INTERPRETED AS AN INGUINO-SCROTAL HERNIA, WITHOUT ANY FURTHER CLINICAL EXAMINATION. ON THE BASIS OF THIS RADIOLOGICAL FINDING ALONE, THE INITIAL HYPOTHESIS OF A VARICOCELE WAS ABANDONED AND SURGERY WAS SCHEDULED PROMPTLY. DURING THE OPERATION, THE SURGEONS REPORTEDLY FOUND NO HERNIA, BUT A PROSTHETIC PATCH (3DMAX MESH) WAS FITTED NONETHELESS. SINCE THIS OPERATION, THE PATIENT IS SUFFERING FROM CHRONIC, DEBILITATING NEUROPATHIC PAIN IN THE GROIN AND LEFT LEG, WITH NEUROLOGICAL IMPAIRMENT CONFIRMED BY VARIOUS MEDICAL EXAMINATIONS. SUBSEQUENTLY, SEVERAL SPECIALIST DOCTORS AND EXPERTS CONSULTED QUESTIONED THE INITIAL DIAGNOSIS OF A HERNIA AND CONCLUDED THAT THE ULTRASOUND IMAGES ACTUALLY CORRESPONDED TO A VARICOCELE, WHICH IS STILL PRESENT TODAY. THE MASS INITIALLY SUSPECTED IS, MOREOVER, STILL PRESENT

  Patient problems: Anxiety; Nerve Damage; Neuropathy; Pain

  MAUDE report 25453153 ↗
• InjuryMay 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST W/ ECHO 2 MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE LEFT UPPER QUADRANT. THE UMBILICAL HERNIA SAC WAS DISSECTED OUT. A VENTRALIGHT ST W/ ECHO 2 MESH (DEVICE 1) WAS PLACED INTO THE ABDOMINAL WALL AND SECURED IT WITH SUTURES.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 2 ¿ RIGHT AND DEVICE 2 ¿ LEFT). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE PREPERITONEAL SPACE INFRAUMBILICAL MIDLINE. BOTH INGUINAL HERNIA SACS WERE DISSECTED OUT. TWO 3DMAX MESH (DEVICE 2 ¿ RIGHT AND DEVICE 2 ¿ LEFT) WAS PLACED INTO THE RIGHT AND LEFT INGUINAL FLOOR AND SECURED IT WITH SUTURES.¿ ON (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH CHRONIC GROIN PAIN, RIGHT AND LEFT ILIOINGUINAL NERVE BLOCK, ADHESION, THEREBY UNDERWENT REVISION SURGERY. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE LEFT UPPER QUADRANT OF THE ABDOMEN. THERE WERE EXTENSIVE ADHESIONS OF OMENTUM AND SMALL BOWELS TO THE ANTERIOR ABDOMINAL WALL

  Patient problems: Adhesion(s); Nerve Damage; Pain

  MAUDE report 25304251 ↗
• InjuryMay 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX (DEVICE 1 AND 2). PER OP NOTES, "ON THE RIGHT INGUINAL REGION, A DIRECT HERNIA WAS NOTED AND REDUCED. A 3DMAX (DEVICE 1) WAS PLACED AND TACKED. ON THE LEFT INGUINAL REGION, AN INDIRECT HERNIA SAC NOTED AND REDUCED. A 3DMAX (DEVICE 2) WAS PLACED AND TACKED." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH HEMATOMA ON LEFT AND RIGHT GROIN THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, "ON THE LEFT SIDE, HEMATOMA WAS OPENED, DISSECTED FREE AND EVACUATED. ON THE RIGHT SIDE, HEMATOMA WAS OPENED AND EVACUATED. BOTH HERNIA REPAIRS APPEARED COMPLETELY INTACT." ON (B)(6) 2022 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 3). PER OP NOTES, "THE HERNIA SAC WAS IDENTIFIED AND FREED FROM THE CORD STRUCTURES. THE HERNIA SAC WAS REDUCED. A PERFIX PLUG (DEVICE 3) WITH ONLAY PATCH WAS PLACED AND SECURED USING SUTURES."

  Patient problems: Hematoma

  MAUDE report 25300820 ↗
• InjuryApr 24, 2026Patient-Device Incompatibility

  AS PER ANSM N° (B)(4): DATE OF OCCURRENCE: (B)(6) 2026 DESCRIPTION OF THE INCIDENT: "RECURRING DISCOMFORT ON EXERTION, FOLLOWED BY DAILY DISCOMFORT WITHOUT EXERTION, AND SUBSEQUENTLY DISCOMFORT AT REST, EVEN WHEN LYING DOWN. THIS DISCOMFORT HAS SINCE BEEN ACCOMPANIED BY DIFFUSE BILATERAL PAIN IN THE SCROTUM AND EVEN THE MID-THIGH, EXTENDING AS FAR AS THE NAVEL, WHICH IS NOW EXPERIENCED DAILY" AS PER SURGICAL REPORT: DATE OF SURGERY: (B)(6) 2021 LAPAROSCOPIC LEFT INGUINAL HERNIA (TAP) CLINICAL HISTORY: TROUBLESOME LEFT INGUINAL HERNIA WITH SUSPECTED RIGHT SPIKE HERNIA INTRAOPERATIVE FINDINGS: INDIRECT LEFT HERNIA, NO CLEAR RIGHT HERNIA. PROCEDURE PERFORMED: PATIENT POSITIONED SUPINE UNDER GENERAL ANAESTHESIA, WITH URINARY CATHETERISATION. PERFORMED AN UMBILICAL LAPAROSCOPY AND, UNDER VISUAL GUIDANCE, INSERTED TWO 5 MM RIGHT AND LEFT PARARECTAL WORKING TROCARS. LEFT SIDE: CONFIRMATION OF AN INDIRECT HERNIA. OPENING OF THE PARIETAL PERITONEUM OPPOSITE THE ANTERIOR SUPERIOR ILIAC SPINE DOWN TO THE LEVEL OF THE UMBILICAL VEIN, ABOVE THE HERNIAL SAC. DISSECTION OF THE LOWER PERITONEAL FLAP, CONVERTING THE ELEMENTS OF THE CORD INTO PARIETAL TISSUE. DISSECTION OF THE UPPER PERITONEAL FLAP.

  Patient problems: Depression; Discomfort; Pain; Sexual Dysfunction

  MAUDE report 24982561 ↗
• MalfunctionMar 13, 2026Material Split, Cut or Torn

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2026, WHILE INSERTING THE 3DMAX MESH THROUGH A TROCAR, THE MESH TORE. THE PROCEDURE WAS COMPLETED USING A NEW MESH, WHICH RESULTED IN A LONGER OPERATION TIME. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595648 ↗
• MalfunctionMar 10, 2026Patient-Device Incompatibility

  AS REPORTED VIA ANSM REPORT (N°R2605557): AS REPORTED THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR ON (B)(6) 2025 WITH THE IMPLANT OF 3DMAX MESH. "INTERVENTION FOR INGUINAL HERNIA ON (B)(6) 2025 I STILL HAVE DISCOMFORT. I HAD AN OPERATION FOR A LEFT INGUINAL HERNIA IN (B)(6) 2025 AND STILL HAVE DISCOMFORT (PRESSURE) DURING THE DAY AND ESPECIALLY AT THE END OF THE DAY. I CAN NO LONGER DO SPORT AND ESPECIALLY NO LONGER CYCLE. DEPRESSION AND NO UNDERSTANDING DOCTORS AND FAMILY." CURRENT PATIENT STATUS: NR. ACTIONS TAKEN IN THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR.

  Patient problems: Depression; Discomfort

  MAUDE report 24562616 ↗
• InjuryMar 5, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED. (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO 3DMAX MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿IN THE LEFT SIDE, AN INDIRECT INGUINAL HERNIA WAS NOTED AND REDUCED. A LEFT LARGE 3DMAX MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED TO THE COOPER¿S LIGAMENT. IN THE RIGHT INGUINAL AREA, THE DEFECT WAS REDUCED AND ANOTHER RIGHT LARGE 3DMAX MESH (DEVICE 2) WAS PLACED AND TACKED TO COOPERS LIGAMENT. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PRIOR MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿IN THE RIGHT INGUINAL AREA, THE FASCIAL HERNIA DEFECT WAS REDUCED AND CLOSED WITH SUTURES. THE MESH (DEVICE 2) WAS INCISED AT THE INGUINAL LIGAMENT AND REMOVED COMPLETELY. SIMILARLY, IN THE LEFT INGUINAL AREA, THE DEFECT WAS REDUCED AND LEFT INGUINAL MESH (DEVICE 1) WAS EXCISED AND FASCIA WAS REAPPROXIMATED WITH SUTURES.¿

  Patient problems: Hernia

  MAUDE report 24517270 ↗
• InjuryMar 3, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM (NO. (B)(4)): AS REPORTED, ON (B)(6) 2024 THE PATIENT UNDERWENT A BILATERAL LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE WITH THE IMPLANT OF TWO 3DMAX MESH (LEFT AND RIGHT). THE MESH DEVICES WERE SECURED WITH A NON-BD/BARD FIXATION SYSTEM. DATE OF OCCURRENCE: (B)(6) 2024. DESCRIPTION OF THE INCIDENT: "SEVERE PAIN IN RIGHT TESTICLE, SUPERFICIAL THROMBOSIS OF THE PENIS, LOSS OF SENSATION IN LEFT THIGH SINCE SURGERY." THE IMMEDIATE POSTOPERATIVE PERIOD WAS UNEVENTFUL, WITH A RETURN TO A NORMAL DIET THAT WAS WELL TOLERATED, IN ACCORDANCE WITH THE ENHANCED RECOVERY AFTER SURGERY PROTOCOL. GIVEN THE FAVORABLE OUTCOME, HE WAS AUTHORIZED TO RETURN HOME THE SAME DAY. OCCURRENCE OF AN ADVERSE EVENT DURING THE STAY: NO. CURRENT PATIENT STATUS: NEUROPATHIC PAIN CHRONIC TESTICULAR PAIN ON THE RIGHT SIDE, UNEXPLAINED CHRONIC URINARY TRACT INFECTIONS, CHRONIC BALANITIS LEADING TO CIRCUMCISION. DEPRESSION, CONTINUED PAIN ON THE RIGHT SIDE, LIKE CRAMPS. LOSS OF SENSATION IN THE LEFT THIGH ABOVE THE KNEE, ON ANTIDEPRESSANTS SINCE (B)(6) 2025. ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR THE PATIENT'S CARE: NR. THIS REPORT REPRESENTS 3DMAX LARGE LEFT.

  Patient problems: Depression; Neuralgia; Numbness; Thrombosis/Thrombus; Urinary Tract Infection

  MAUDE report 24498055 ↗
• InjuryMar 3, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM REPORT (B)(4): AS REPORT, THE PATIENT UNDERWENT IMPLANT OF TWO 3DMAX MESH (LEFT AND RIGHT) DEVICES ON (B)(6) 2021, DURING THE REPAIR OF BILATERAL INGUINAL HERNIAS. DATE OF EVENT - 12-JUN-2021 DESCRIPTION OF THE INCIDENT: PAIN IN THE LOWER ABDOMEN AND THIGHS. COMMENTS: MRI (B)(6) 2021: SMALL FLUID POCKET AROUND THE PROSTHESES. PATIENT'S CURRENT CONDITION : UNBEARABLE PAIN 24 HOURS A DAY. DIFFICULTY WALKING, SLEEPING. ACTIONS TAKEN IN THE HOSPITAL TO MANAGE THE PATIENT: NR THIS REPORT REPRESENTS 3DMAX MESH LEFT.

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Seroma

  MAUDE report 24496588 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX (DEVICE 1 AND 2). PER OP NOTES, ¿ON THE RIGHT INGUINAL REGION, A LARGE DIRECT HERNIA SAC WAS NOTED AND SEPARATED FROM CORD STRUCTURES AND DISSECTED FREE. THE SAC WAS EXTRACTED AND REMOVED. A 3DMAX (DEVICE 1) WAS PLACED IN THE PERITONEAL SPACE AND SUTURED. ON THE LEFT INGUINAL REGION, A DIRECT HERNIA SAC WAS NOTED AND EXCISED. A 3DMAX (DEVICE 2) WAS PLACED IN THE PERITONEAL SPACE AND SUTURED.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE PERITONEUM WAS OPENED. A MODERATE AMOUNT OF FREE FLUID WAS DRAINED. SMALL BOWEL WAS EXTRACTED. A LOOP OF SMALL BOWEL HAD HERNIATED THROUGH A SMALL DEFECT IN THE PERITONEUM AND WAS ADHERENT TO THE PRIOR MESH (DEVICE 1 AND 2) USED FOR THE PRIOR HERNIA REPAIR. THE SMALL BOWEL WAS FREED FROM THE MESHES AND REDUCED BACK INTO PERITONEAL CAVITY. THE PERITONEAL DEFECT WAS CLOSED SUTURES.¿

  Patient problems: Abdominal Pain; Adhesion(s); Obstruction/Occlusion

  MAUDE report 24380805 ↗
• InjuryFeb 11, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO 3DMAX MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿A SMALL DIRECT BILATERAL HERNIAS WERE NOTED. IN THE RIGHT SIDE, HERNIAS WERE REDUCED AND 3DMAX MESH (DEVICE 1) WAS PLACED. IN THE LEFT SIDE, HERNIA WAS REDUCED AND ANOTHER 3DMAX MESH (DEVICE 2) WAS PLACED OVER THE INGUINAL DEFECT. THE FASCIAL DEFECT WAS CLOSED WITH SECURED WITH SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA AND GROIN PAIN THEREBY UNDERWENT OPEN REPAIR WITH BILATERAL GROIN EXPLORATION AND REMOVAL OF PREVIOUSLY PLACED MESHES (DEVICE 1 AND 2) AND IMPLANT OF BIOLOGICAL GRAFT. PER OPERATIVE NOTES, ¿IN THE LEFT SIDE, THE MESH (DEVICE 2) WAS REMOVED FROM THE SUBCUTANEOUS TISSUES AND SIMILARLY IN RIGHT SIDE, THE MESH (DEVICE 1) WAS REMOVED. THE RECURRENT BILATERAL DEFECTS WERE REDUCED AND BIOLOGICAL GRAFT WAS PLACED FASCIA WAS CLOSED WITH SUTURES AND SECURED CIRCUMFERENTIALLY.¿

  Patient problems: Hernia; Pain

  MAUDE report 24311989 ↗
• InjuryFeb 10, 2026Patient-Device Incompatibility

  AS REPORTED BY PATIENT VIA ANSM REPORT (N° (B)(4): "I HAD MY FIRST SURGERY ON (B)(6) 2023, FOR A LEFT AND RIGHT INGUINAL HERNIA. A BECTON DICKINSON 3DMAX MESH WAS PLACED ON EACH SIDE OF MY ABDOMEN. FOLLOWING PAIN ON THE RIGHT SIDE, I UNDERWENT A SECOND OPERATION ON (B)(6) 2024. A COUSIN BIOSERV BIOMESH PLATE WAS PLACED, BUT THE PAIN IS STILL PRESENT ON THE RIGHT SIDE. THERE IS ALSO PAIN ON THE LEFT SIDE, BUT IT IS LESS SEVERE." ON (B)(6) 2023, THE PATIENT UNDERWENT BILATERAL INGUINAL HERNIA REPAIR BY LAPAROSCOPIC APPROACH (MHJ) AND IMPLANTED WITH 3DMAX MESH LEFT AND RIGHT. ON (B)(6) 2024, A LICHTENSTEIN BIOMESH A2 PLATE WAS IMPLANTED. CURRENT PATIENT STATUS: NR. ACTIONS TAKEN AT THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR. THIS REPORT REPRESENTS DEVICE #1 (3DMAX-LEFT).

  Patient problems: Abdominal Pain

  MAUDE report 24306398 ↗
• InjuryFeb 3, 2026Patient-Device Incompatibility

  AS PER ANSM REPORT ((B)(4)): DESCRIPTION OF THE INCIDENT: "SINCE THESE IMPLANTS WERE FITTED, AND DESPITE NUMEROUS REPORTS TO MY GP AND THE SURGEON WHO FITTED THE IMPLANTS (3DMAX MESH LEFT- DEVICE 1 / 3DMAX RIGHT- DEVICE 2), I HAVE BEEN SUFFERING FROM NUMEROUS ADVERSE EFFECTS ABDOMINAL AND PELVIC PAIN DURING SEXUAL INTERCOURSE DURING EJACULATION, SOMETIMES INCAPACITATING. PERMANENT DIGESTIVE PROBLEMS SIGNIFICANT PAIN WITH ACUTE ATTACKS EVERY MORNING. PAIN DURING EXERTION, WALKING, DRIVING, SITTING OR BENDING (TYING SHOELACES). SIGNIFICANT AND PAINFUL BLOATING. SEVERE AEROPHAGIA. SEVERE FATIGUE INSOMNIA IRRITABILITY DEVELOPMENT OF FOOD INTOLERANCES, SUCH AS DAIRY PRODUCTS. HALITOSIS DESPITE GOOD DENTAL HYGIENE AND REGULAR CHECK-UPS. FEELING OF A HARD FOREIGN BODY (LIKE A PEBBLE). CURRENT CONDITION OF PATIENT: NR. ACTIONS TAKEN BY THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR.

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Discomfort; Fatigue; Heartburn/Indigestion; Unspecified Gastrointestinal Problem

  MAUDE report 24247491 ↗
• InjuryJan 29, 2026Material Deformation

  PER ANSM REPORT (B)(4). IN SUMMARY: DATE OF OCCURRENCE:(B)(6) 2022 PROSTHESIS FITTED ON (B)(6) 2022 PAINFUL SYMPTOMS APPEARED ONE WEEK LATER. BURNING SENSATIONS, STABBING PAINS AND ELECTRIC SHOCKS DOWN THE LEFT LEG. NUMEROUS PAINKILLERS TRIED. DECISION TO REMOVE THE PROSTHESIS ON (B)(6) 2022 BY LAPAROSCOPY FOLLOWED BY MINI LAPAROTOMY. REMOVAL OF THE PLATE THAT HAD RETRACTED. INTERNAL HAEMORRHAGE ON (B)(6) 2022. EMERGENCY RETURN TO THE OT. LARGE LAPAROTOMY. COMPRESSION OF THE PSOAS MUSCLE. REHABILITATION TO WALK FOR SEVERAL MONTHS. INCREASINGLY SEVERE DEBILITATING PAIN ON A DAILY BASIS. FOLLOW-UP AT PAIN MANAGEMENT CENTRE. ON (B)(6) 2022 PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF LEFT FEMORAL HERNIA. PREPERITONEAL PROSTHESIS. INDICATION: PATIENT WHO HAD A LEFT INGUINAL HERNIA FOR SEVERAL YEARS BUT HAS BECOME SYMPTOMATIC AND PAINFUL DURING STRENUOUS ACTIVITY. INDICATION FOR LAPAROSCOPIC REPAIR OF LEFT INGUINAL HERNIA ON (B)(6) 2022. SURGICAL TECHNIQUE: INSERTION OF TWO 5 MM TROCARS IN THE LEFT AND RIGHT FLANKS. PERITONEAL INCISION FROM THE ANTERIOR ILIAC SPINE TO LEFT UMBILICAL ARTERY, PASSING OVER THE HERNIAL SAC. REDUCTION OF THE HERNIAL SAC. PARIETALISATION OF THE CORD. PLACEMENT OF

  Patient problems: Adhesion(s); Bacterial Infection; Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain; Paresthesia

  MAUDE report 24209469 ↗
• InjuryJan 13, 2026Patient-Device Incompatibility

  AS PER ANSM REPORT: (B)(4). SUMMARY OF REPORTED EVENT: (B)(6) 2025 ¿ PATIENT HAD BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO BARD 3DMAX MESH (DEVICE 1, 2). PER OP NOTES, ¿BILATERAL DIRECT INGUINAL HERNIA WAS REVEALED. THE ANTERIOR PARIETAL PERITONEUM ABOVE THE HERNIAL SAC WAS DISSECTED. A 10.8X16CM BARD PROSTHESIS (DEVICE 1) ON THE LEFT AND AN 8.5X13.7CM PROSTHESIS (DEVICE 2) ON THE RIGHT WERE PLACED AND CLOSED USING SUTURES.¿ (B)(6) 2025 ¿PATIENT EXPERIENCED PAIN IN LOWER PELVIS WHICH RADIATED TO THE TESTICLES, INNER THIGH AND ANUS. AN ULTRASOUND AND PELVIC CT SCAN CONFIRMED THE RECURRENCE OF BOTH INGUINAL HERNIAS, AS WELL AS THE APPEARANCE OF A SMALL UMBILICAL HERNIA. (B)(6) 2025 ¿ PATIENT HAD DEBILITATING PAIN AND WAS DIAGNOSED WITH BILATERAL PRE-HERNIAL LIPOMA THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿ON LEFT SIDE, THE SPERMATIC CORD IS IDENTIFIED AND LIGATED. DISSECTION OF THE PRE-HERNIAL LIPOMA CONFIRMED THE PRESENCE OF AN INDIRECT HERNIA WITH FATTY CONTENT. THE HERNIA WAS RESECTED. THE PARIETAL SUBSTANCE LOSS WAS REPAIRED BY PLACING AN UNKNOWN PROTHESIS WHICH FIXED TO PUBIC SPINE, CRURAL ARCH, TENDON JOINT USING SUTURES. ON RI

  Patient problems: Ambulation or Postural Difficulties; Hernia; Pelvic Pain; Unspecified Gastrointestinal Problem; Weight Changes

  MAUDE report 24052706 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH BILATERAL SYMPTOMATIC INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1 ¿ RIGHT AND DEVICE 2 ¿ LEFT). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE JUST BELOW THE UMBILICUS. ON THE RIGHT SIDE RIGHT INGUINAL HERNIA SAC WAS DISSECTED OUT. A 3DMAX MESH (DEVICE 1- RIGHT) WAS PLACED AND SECURE IT WITH SUTURES. ON THE LEFT INGUINAL SIDE, HERNIA SAC WAS DISSECTED OUT. A 3DMAX MESH (DEVICE 2 ¿ LEFT) WAS PLACED ON THE LEFT INGUINAL HERNIA SITE AND SECURE IT WITH SUTURES.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 3). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE RIGHT GROIN. THE SPERMATIC CORD WAS THEN DISSECTED OUT. THE HERNIA SAC WAS DISSECTED OUT. A PERFIX PLUG (DEVICE 3) WAS PLACED INTO THE RIGHT INGUINAL SITE AND SECURE IT WITH SUTURES.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE MIDPORTION OF THE EXTERNAL OBLIQUE. THE LEFT INGUINAL HERNIA SAC WAS DISSECT

  Patient problems: Hernia

  MAUDE report 23942761 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO 3DMAX MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿IN THE LEFT PREPERITONEAL INGUINAL SPACE, AN INDIRECT INGUINAL HERNIA WITH SAC WAS REDUCED. A LARGE SIZE 3DMAX MESH (DEVICE 1) WAS PLACED ON HERNIA DEFECT WALL AND SECURED WITH SUTURES. IN THE RIGHT PREPERITONEAL INGUINAL SPACE, AN INDIRECT INGUINAL HERNIA WITH SAC WAS REDUCED. A MEDIUM SIZE, 3DMAX MESH (DEVICE 2) WAS PLACED INTO THE POSITION TO COVER THE HERNIA DEFECT. ¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 3). PER OPERATIVE NOTES, ¿EXTENSIVE ADHESIONS AND SMALL RECURRENT RIGHT INGUINAL HERNIA WAS NOTED AND REDUCED. A MEDIUM SIZE, 3DMAX MESH (DEVICE 3) WAS PLACED COVERING RECURRENT HERNIA DEFECT. THE MESH (DEVICE 2) WAS REPLACED IN PRIOR POSITION WHICH SLIGHTLY OVERLAPPED NEW MESH (DEVICE 3). IN THE LEFT SIDE, EXTENSIVE ADHESIONS OF PRIOR MESH (DEVICE 1) TO ANTERIOR ABDOMINAL WALL WAS REDUCED. THE HERNIA CONTENT CONTAINED HALF OF PRIOR PLACED MESH (DEVICE 1). THE MESH (

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23941203 ↗
• MalfunctionDec 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A PIECE OF PLASTIC (MESH) WAS FOUND INSIDE THE PACKAGING OF A 3DMAX MESH. IT WAS REPORTED THAT THE OUTER AND THE INNER PACKAGING WAS INTACT AND FULLY SEALED AT THE TIME PRIOR TO OPENING. ANOTHER PRODUCT IN STOCK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875930 ↗
• InjuryNov 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT KEYHOLE HERNIA (LEFT INGUINAL) REPAIR USING A 3DMAX MESH ON (B)(6) 2024. POST SURGERY PATIENT HAS EXPERIENCED CHRONIC PAIN, NERVE ENTRAPMENT AND RECURRENCE OF THE HERNIA. THE CONDITION IS TREATED BY OTC MEDICATION FOR PAIN MANAGEMENT. PATIENT HAD A CONSULTATION FOR NEURECTOMY BUT HAS DECIDED AGAINST THIS PROCEDURE FOR NOW. CURRENT CONDITION OF THE PATIENT IS STABLE AND WILL HAVE REVISION SURGERY TO REPAIR THE HERNIA.

  Patient problems: Hernia; Nerve Damage; Pain

  MAUDE report 23630232 ↗
• InjuryOct 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO 3DMAX MESH (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿IN THE LEFT SIDE, INDIRECT HERNIA WAS REDUCED AND LARGE 3DMAX MESH (DEVICE 1) WAS PLACED AND SUTURED. THERE WAS A LARGE DIRECT AND INDIRECT PORTION OF HERNIA IN RIGHT SIDE THAT WAS REDUCED AND ANOTHER LARGE 3DMAX MESH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES.¿ ON (B)(6) 2017: PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND CHRONIC PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF POLYPROPYLENE MESH WITH KEYHOLE. PER OPERATIVE NOTES, ¿AN INDIRECT LEFT INGUINAL HERNIA SAC WAS DISSECTED AND ADHESIONS WITH FATTY TISSUES WERE LYSED. A LARGE POLYPROPYLENE MESH WITH KEYHOLE WAS PLACED AND SECURED WITH SUTURES.¿ (NOTE: THE MESH IMPLANTED IN THIS PROCEDURE IS UNKNOWN AND THERE IS NOT ANY PRODUCT IDENTIFIER PROVIDED FOR THIS PRODUCT). ON (B)(6) 2017: PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF POLYPROPYLENE MESH WITH KEYHOLE. PER OPERATIVE NOTES, ¿THE INDIRECT HERNIA SAC WITH ADHESIONS WERE REM

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 23439624 ↗
• InjuryOct 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013- PATIENT WAS DIAGNOSED WITH BILATERAL SPORTS INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC-ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1 AND 2). PER OP NOTES, ¿A SMALL INDIRECT BILATERAL INGUINAL HERNIA WAS NOTED. INITIALLY, IN THE RIGHT INGUINAL REGION, THE DEFECT WAS DISSECTED AND REPAIRED USING A 3DMAX MESH (DEVICE 1), WHICH WAS THEN SUTURED. SUBSEQUENTLY, IN THE LEFT INGUINAL REGION, THE DEFECT WAS DISSECTED, AND A 3DMAX MESH (DEVICE 2) WAS PLACED AND SUTURED¿. (B)(6) 2014- PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT GROIN PAIN, THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE ILIOINGUINAL NERVE IN RIGHT INGUINAL REGION WAS IDENTIFIED, ISOLATED AND PASSED OFF¿. (B)(6) 2015- PATIENT WAS DIAGNOSED WITH RECURRENT LEFT GROIN PAIN, THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE ILIOINGUINAL NERVE IN LEFT INGUINAL REGION WAS IDENTIFIED, ISOLATED AND PASSED OFF¿. (B)(6) 2019- PATIENT WAS DIAGNOSED WITH RECURRENT DIRECT BILATERAL INGUINAL HERNIAS, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 3 AND 4). PER OP NOTES, ¿INITIALLY IN THE RIGHT INGUINAL REGION, A DIRECT INGUINAL HERNIA DEFECT WAS IDENTIFIED ALON

  Patient problems: Nerve Damage; Pain

  MAUDE report 23438373 ↗
• InjuryOct 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1) AND 3DMAX MESH (DEVICE 2). (NOTE: THERE IS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INFECTION; FLUID COLLECTION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF INFECTED MESH (DEVICE 1 AND DEVICE 2). PER OP NOTES, ¿THE LARGE FLUID COLLECTION WAS NOTED. THE MESH (DEVICE 1 AND DEVICE 2) PALPABLE UNDERNEATH THE EXTERNAL OBLIQUE WAS REMOVED.¿

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 23365879 ↗
• InjuryOct 23, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2018- PATIENT WAS DIAGNOSED WITH BILATERALLY INDIRECT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC-ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC IN THE RIGHT INGUINAL REGION WAS IDENTIFIED AND WAS DISSECTED. RIGHT INGUINAL HERNIA WAS QUITE LARGE. THEREFORE, IT WAS DECIDED TO PERFORM LEFT INGUINAL HERNIA REPAIR IN 6 WEEKS. A 3DMAX (DEVICE 1) WAS PLACED IN THE PERIPERITONEAL REGION AND SUTURED¿. (B)(6) 2018- PATIENT WAS DIAGNOSED WITH LEFT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC-ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX (DEVICE 2). PER OP NOTES, ¿THE HERNIA SAC IN THE LEFT INGUINAL REGION WAS IDENTIFIED AND DISSECTED. A 3DMAX (DEVICE 2) WAS PLACED IN THE LEFT INGUINAL REGION AND SUTURED¿. (B)(6) 2019- PATIENT WAS DIAGNOSED WITH PELVIC AND LEFT GROIN PAIN, THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH EXPLANT OF 3D MAX MESH (DEVICE 2). PER OP NOTES, ¿SCAR TISSUE AND ADHESION WERE NOTICED AND THE LEFT-SIDED MESH IS ACCORDIONED AT THE MEDIAL ASPECT BETWEEN THE PUBIC BONE AND THE BLADDER. 3DMAX (DEVICE 2) WAS EXCISED.¿

  Patient problems: Adhesion(s); Pain; Scar Tissue

  MAUDE report 23365697 ↗