BARD 0113710Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741030703), received between Jul 11, 2017 and Jul 31, 2026 — classified as 42 injuries.

The most frequently reported specific device problem is “Defective Device” (29 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Patient-Device Incompatibility

  As reported in summary Per ANSM No (b)(4):Reportedly, "My pain relating to the hernia prosthesis began in (b)(6) 2025. I underwent surgery (Pre-shaped Mesh implant) on (b)(6) 2020 following the detection of an inguinal hernia in 2019. Apart from sporadic pain that tended to go away, I did not have any major problems with this prosthesis for the first four years. In (b)(6) 2025, following a sudden awkward movement, I experienced severe pain in my groin. As this pain was very similar to that of an inguinal hernia, I assumed it would eventually go away. This was not the case, however, and the pain became chronic."2026, Patient reported joint and muscle pain, fatigue and weakness. Patient attended the ED where neuropathic pain was diagnosed, CT scan revealed no recurrent hernia. Multiple investigations including MRI, abdominal and pelvic CT scan, blood tests and ultrasound, no diagnosis was identified to explain the hernia-related pain. Several specialists suggested the hernia prosthesis may be the cause. As of (b)(6) 2026, Patient reported severe chronic hernia pain radiating through the pelvic region, thigh and abdomen, severe and constant muscle and joint pain affecting quality of l

  Patient problems: Arthralgia; Discomfort; Fatigue; Hernia; Myalgia; Neuropathy

  MAUDE report 50101363 ↗
• InjuryApr 21, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL PANTALOON SLIDER HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1) AND BARD PRE-SHAPED MESH WITH KEYHOLE (DEVICE 2). PER OPERATIVE NOTES, "IN THE RIGHT GROIN AREA, A HUGE SAC WITH LARGE DEEP OPENING AND SLIDER COMPONENT WAS TAKEN DOWN AND SAC WAS CLOSED WITH SUTURES. A MEDIUM SIZED PERFIX PLUG (DEVICE 1) WAS PLACED MEDIAL TO THE CORD AND TRANSVERSALIS FASCIA WAS CLOSED OVER IT. THE MESH (DEVICE 1) PARTIALLY CLOSED THE INTERNAL RING AND A LARGE SIZE BARD PRE-SHAPED MESH WITH KEYHOLE (DEVICE 2) WAS PLACED IN POSITION AND TACKED DOWN TO THE PUBIC TUBERCLE, INGUINAL LIGAMENT AND RECTUS FASCIA. THE EXTERNAL OBLIQUE WAS CLOSED OVER THE CORD AND SECURED WITH SUTURES." (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 3). PER OPERATIVE NOTES, " THROUGH THE OLD RIGHT GROIN INCISION, THE HERNIA WAS NOTED. THE SURFACE OF THE CORD, HERNIA WERE DISSECTED FREE AND DIRECT DEFECT THROUGH THE INTERNAL RING WAS REDUCED BACK THROUGH THE DEFECT. THE OLD MESH (DEVICE 1) WAS SEEN DRIFTED MEDIALLY T

  Patient problems: Hernia; Pain

  MAUDE report 24935994 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  AS REPORTED VIA ANSM REPORT NO.(B)(4): AS REPORTED, THE PATIENT UNDERWENT INGUINAL HERNIA REPAIR ON (B)(6) 2019 WITH IMPLANT OF BARD PRE-SHAPED MESH. DATE OF OCCURRENCE: (B)(6) 2019. DESCRIPTION OF THE INCIDENT: "I HAD SURGERY FOR AN INGUINAL HERNIA IN 2019 AND WAS FITTED WITH A BRAUN PLATE." OPERATIVE REPORT: CLINICAL BACKGROUND: THE PATIENT WITH A HISTORY OF LEFT INGUINAL HERNIA ACCORDING TO LICHTENSTEIN IN 2012 AND A PENILE WOUND IN 2009, CURRENTLY PRESENTING WITH A RIGHT INGUINAL-SCROTAL HERNIA COMPLICATED BY AN EPISODE OF STRANGULATION IN (B)(6) 2019, FOR WHICH INGUINAL PLATE REPAIR IS INDICATED. DIAGNOSIS OR OPERATIVE FINDINGS: EXTERNAL OBLIQUE RIGHT INGUINAL HERNIA. PROCEDURE OR ACTIONS PERFORMED: INGUINAL PLATE REPAIR ACCORDING TO LICHTENSTEIN. UNDER GENERAL ANESTHESIA, IN THE SUPINE POSITION. AFTER LOCOREGIONAL INFILTRATION WITH 2% NAROPAIN PER 1000. RIGHT INGUINAL INCISION AND OPENING OF THE EXTERNAL OBLIQUE APONEUROSIS. THE CORD IS ISOLATED AND LIGATED. PRESENCE OF A LARGE RIGHT EXTERNAL OBLIQUE HERNIA. THE SAC WAS FREED UP TO THE LEVEL OF THE NECK, RESECTED AND CLOSED AT THE NECK WITH VICRYL SUTURES. NO ASSOCIATED DIRECT HERNIA. A BARD MESH WAS PLACED AND FIXED TO THE J

  Patient problems: Pain

  MAUDE report 24701125 ↗
• InjuryFeb 23, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM REPORT (NO (B)(4)): AS REPORTED A MALE PATIENT BORN IN 1974 WAS IMPLANTED WITH A BARD MESH PRE-SHAPED W/ KEYHOLE ON (B)(6) 2022. DATE OF OCCURRENCE: (B)(6) 2022 DESCRIPTION OF INCIDENT: MALE BORN IN 1974 - 73 KG. "WHEN I WOKE UP AFTER THE OPERATION TO INSERT A RIGHT INGUINAL PROSTHESIS, I WAS UNABLE TO GET UP BECAUSE THE PAIN WAS TOO INTENSE. I HAVE BEEN IN A GREAT DEAL OF PAIN EVER SINCE. AFTER SEVERAL CHECK-UPS, IT HAS BEEN IMPOSSIBLE TO DETERMINE A MEDICAL REASON FOR MY SUFFERING. CURRENT CONDITION OF THE PATIENT: TO DATE, THE PAIN IS STILL PRESENT, DAY AND NIGHT, WITH STABBING PAINS IN THE LOWER ABDOMEN AND GROIN AREA. SEVERE AND DEBILITATING PAIN. I HAVE GREAT DIFFICULTY WALKING AND NO LONGER PARTICIPATE IN SPORTS OR LEISURE ACTIVITIES. I CAN NO LONGER WORK AND HAVE BEEN DISMISSED BY OCCUPATIONAL HEALTH, DESPITE NUMEROUS MEDICATIONS, THE EFFECTS OF WHICH REMAIN INEFFECTIVE. TODAY, I HAVE GIVEN UP AND HIT ROCK BOTTOM. I HAVE BEEN UNDERGOING TREATMENT SINCE 2023 WITH A PSYCHOLOGIST AND PSYCHIATRIST (CSM) FOLLOWING SEVERE DEPRESSION AND NUMEROUS TREATMENTS. I ALSO REPORT PAIN IN MY GENITALS, MAKING SEXUAL INTERCOURSE VERY PAINFUL. I HAVE NOT BEEN ABLE TO LIVE

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Depression; Sexual Dysfunction

  MAUDE report 24413360 ↗
• InjuryJan 29, 2026Patient-Device Incompatibility

  AS REPORTED BY PATIENT VIA ANSM REPORT (N° R2601069): DATE OF OCCURRENCE: (B)(6) 2023 DESCRIPTION OF THE INCIDENT: PERIOD OF OCCURRENCE: 11 MONTHS AFTER THE OPERATION IN (B)(6) 2024. ELEVEN MONTHS AFTER INGUINAL HERNIA SURGERY, I BEGAN TO EXPERIENCE PAIN IN THE OPERATED AREA, ABDOMINAL SWELLING AND A CONSTANT URGE TO HAVE A BOWEL MOVEMENT. I UNDERWENT A DOZEN TESTS (COLONOSCOPY, GASTROSCOPY, VARIOUS IMAGING TESTS, CONSULTATIONS WITH THE SURGEON, INTERNAL MEDICINE, ETC.). THE IMAGING TESTS DETECTED AN EFFUSION IN THE AREA WHERE I HAD SURGERY, BUT NO SOLUTION WAS OFFERED TO ME. ON (B)(6) 2023 THE PATIENT UNDERWENT UNILATERAL HERNIA REPAIR IN THE GROIN WITH PROSTHESIS VIA LAPAROTOMY [ABDOMINAL WALL] DURATION OF PROCEDURE: 1 HOUR AND 25 MINUTES. CLINICAL SUMMARY: THIS IS A 37-YEAR-OLD PATIENT WHO HAS BEEN COMPLAINING OF A SWELLING IN THE RIGHT GROIN AREA FOR ABOUT A MONTH, WHICH CAN BE REDUCED SPONTANEOUSLY, WITH DISCOMFORT ASSOCIATED WITH EXERTION. CLINICALLY, THERE IS A RIGHT INGUINAL HERNIA THAT CAN BE REDUCED PERFECTLY. NO CONTRALATERAL HERNIA. THE INDICATION IS FOR OPEN HERNIA REPAIR ACCORDING TO LICHTENSTEIN WITH PROSTHESIS PLACEMENT. PATIENT INFORMED OF THE RISKS AND UNCERTAINTI

  Patient problems: Abdominal Pain; Fecal Urgency; Swelling/ Edema

  MAUDE report 24213775 ↗
• InjuryNov 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A UNILATERAL OBLIQUE INGUINAL HERNIA REPAIR, THE PATIENT WAS IMPLANTED WITH BARD MESH PRE-SHAPED W/ KEYHOLE ON (B)(6) 2024. IT WAS REPORTED THAT FOLLOWING THE IMPLANT PATIENT REPORTED OBVIOUS PAIN IN THE INGUINAL AREA OF THE RIGHT LOWER ABDOMEN AND A FOREIGN BODY SENSATION. IT WAS ALSO REPORTED THAT UNDER CAREFUL EXAMINATION BY THE SURGEON, IT WAS FOUND THAT THE PATIENT HAD A MILD REJECTION REACTION TO THE FOREIGN BODY AND THE PATIENT WAS CONTINUED TO OBSERVE AND TREAT THE SYMPTOMS.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20633812 ↗
• InjuryAug 22, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE WITH THE IMPLANT OF A PRE-SHAPED MESH ON (B)(6) 2024. FOUR HOURS POSTOPERATIVELY THE PATIENT HAD ERYTHEMA AND ITCHING SYMPTOMS IN THE AFFECTED AREA AND WAS GIVEN DESENSITIZATION TREATMENT. THE SYMPTOMS DISAPPEARED AFTER ONE HOUR.

  Patient problems: Erythema; Itching Sensation

  MAUDE report 20031113 ↗
• InjuryApr 10, 2024Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD SOFT MESH ON (B)(6) 2022 AND/OR (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2022 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF THE BARD PRE-SHAPED MESH WITH KEYHOLE (DEVICE #1). PER OPERATIVE NOTES, ¿A BARD PRE-SHAPED MESH WITH KEYHOLE (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2022 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD PRE-SHAPED MESH WITH KEYHOLE (DEVICE #1) AND IMPLANT ONE BARD SOFT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE OLD MESH (DEVICE #1) WAS DISSECTED. THE GROIN WAS IRRIGATED. A BARD SOFT MESH (DEVICE #2) WAS PLACED AND SECURE IT WITH SUTURE.¿

  Patient problems: Hernia; Insufficient Information

  MAUDE report 19078020 ↗
• InjuryJan 31, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH LARGE PRE-SHAPED WITH KEYHOLE ON (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH LARGE PRE-SHAPED WITH KEYHOLE. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 18611945 ↗
• InjuryJan 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, AFTER EIGHT HOURS OF HERNIA REPAIR PROCEDURE WITH THE IMPLANT OF A PRE-SHAPED MESH ON (B)(6) 2023, THE PATIENT HAD ERYTHEMA AND ITCHING SYMPTOMS IN THE AFFECTED AREA AND WAS GIVEN DESENSITIZATION TREATMENT. THE SYMPTOMS DISAPPEARED AFTER ONE HOUR.

  Patient problems: Erythema; Itching Sensation

  MAUDE report 18434203 ↗
• InjuryNov 20, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, AFTER EIGHT HOURS OF HERNIA REPAIR PROCEDURE WITH THE IMPLANT OF PRE-SHAPED MESH ON 08-SEP-2023, PATIENT HAD ERYTHEMA AND ITCHING SYMPTOMS IN THE AFFECTED AREA AND WAS GIVEN DESENSITIZATION TREATMENT. THE SYMPTOMS WAS DISAPPEARED AFTER ONE HOUR.

  Patient problems: Erythema; Itching Sensation

  MAUDE report 18169621 ↗
• InjuryMay 25, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS IMPLANTED WITH PRE-SHAPED MESH W/ KEYHOLE ON (B)(6) 2023. IT WAS REPORTED THAT 5 DAYS POST-IMPLANT OF THE MESH, THE PATIENT DEVELOPED LOCAL REDNESS AND STIFFNESS OF THE WOUND. IT WAS ALSO REPORTED THAT THE PATIENT SYMPTOMS HAVE BEEN TREATED BY LOCAL HOT COMPRESS AND PHYSIOTHERAPY. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Erythema

  MAUDE report 17001293 ↗
• InjuryMar 17, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL PERFIX PLUG AND BARD MESH LARGE PRE-SHAPED WITH KEYHOLE ON (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 16563326 ↗
• InjuryDec 22, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH ( BARD FLAT MESH). ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT". IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 16034502 ↗
• InjuryDec 22, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Pain

  MAUDE report 16034202 ↗
• InjuryMar 8, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PRE-SHAPED MESH WITH KEYHOLE (THE PRODUCT). IT IS ALLEGED THAT ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH THE PRODUCT IN THE COURSE OF A LEFT INGUINAL HERNIA REPAIR SURGERY. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF CHRONIC PAIN. IT IS ALLEGED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT CORRECTIVE REVISION SURGERIES. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED INJURIES, LOSSES, AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES. IT IS ALLEGED THAT THE IMPLANTATION AND FAILURE OF THE PRODUCT HAS HAD A DEVASTATING IMPACT ON THE PATIENT, LEAVING THE PATIENT WITH PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT, AND CHRONIC PAIN. IT IS ALLEGED THAT THE PATIENT'S ADVERSE REACTION, COMPLICATIONS, AND FURTHER SURGERY DIRECTLY AND PROXIMATELY RESULTED FROM THE DEFECTIVE AND DANGEROUS CONDITION OF THE PRODUCT. IT IS ALLEGED THAT THE INJURIES DUE TO THE IMPLANTATION OF THE PRODUCT HAVE CAUSED AND CONTINUE TO CAUSE THE PATIENT EXPERIENCED PAIN, SUFFERING,

  Patient problems: Deformity/ Disfigurement; Pain; Scar Tissue

  MAUDE report 13695961 ↗
• InjuryDec 7, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL PERFIX PLUG ON (B)(6) 2020 (X2). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Nerve Damage; Scar Tissue

  MAUDE report 12951183 ↗
• InjuryDec 2, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH), BARD SOFT MESH AND BARD MESH PRE- SHAPED WITH KEYHOLE ON (B)(6)2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 12914752 ↗
• InjuryOct 7, 2021Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Scar Tissue

  MAUDE report 12588501 ↗
• InjuryAug 17, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL PERFIX PLUG. AS REPORTED THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BARD MESH (BARD FLAT MESH) WHICH WAS IMPLANTED ON (B)(6) 2014. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 12331890 ↗
• InjuryAug 14, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH 2 BARD PRE-SHAPED MESHES IN COURSE OF AN UMBILICAL AND INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2014. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF RECURRENT LEFT INGUINAL HERNIA, PAIN AND SWELLING IN THE LEFT GROIN AND EXTERNAL OBLIQUE WAS ATTACHED TO THE UNDERLYING MESH. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT REVISION SURGERY WHICH REQUIRED REMOVAL OF THE MESH AND PLACEMENT OF ALTERNATIVE MESH TO REPAIR THE RECURRING HERNIA ON OR ABOUT (B)(6) 2015. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED INJURIES, LOSSES AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUFFERING, INCLUDING CHRONIC PAIN. IT IS ALSO ALLEGED THE PATIENT WAS TREATED WITH A COURSE OF HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS AND REST. ATTORNEY ALLEGES THAT THE PATIENT WILL REQUIRE FURTHER INVASIVE REPAIR SURGERY, PHYSIOTHERAPY, REHABILITATION AND WILL CONTINUE TO REQUIRE OTHER FOR

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 12322244 ↗
• InjuryAug 14, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH 2 BARD PRE-SHAPED MESHES IN COURSE OF AN UMBILICAL AND INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2014. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF RECURRENT LEFT INGUINAL HERNIA, PAIN AND SWELLING IN THE LEFT GROIN AND EXTERNAL OBLIQUE WAS ATTACHED TO THE UNDERLYING MESH. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT REVISION SURGERY WHICH REQUIRED REMOVAL OF THE MESH AND PLACEMENT OF ALTERNATIVE MESH TO REPAIR THE RECURRING HERNIA ON OR ABOUT (B)(6) 2015. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED INJURIES, LOSSES AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUFFERING, INCLUDING CHRONIC PAIN. IT IS ALSO ALLEGED THE PATIENT WAS TREATED WITH A COURSE OF HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS AND REST. ATTORNEY ALLEGES THAT THE PATIENT WILL REQUIRE FURTHER INVASIVE REPAIR SURGERY, PHYSIOTHERAPY, REHABILITATION AND WILL CONTINUE TO REQUIRE OTHER FOR

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 12322243 ↗
• InjuryMay 12, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS PER (B)(6): ON (B)(6) 2021, THE PATIENT UNDERWENT A TENSION-FREE REPAIR OF UNILATERAL INDIRECT INGUINAL HERNIA UNDER EPIDURAL ANESTHESIA AND WAS IMPLANTED WITH A BARD/DAVOL PRE-SHAPED MESH WITH KEYHOLE. ON (B)(6) 2021 THE PATIENT FELT ITCHING AND DISCOMFORT AT THE WOUND SITE. WHEN CHECKED, THE WOUND WAS FREE OF REDNESS, AND SWELLING. SUBCUTANEOUS FLUID, REGARDLESS OF WOUND INFECTION, PATIENT WAS GIVEN ANTI-ALLERGIC SYMPTOMATIC TREATMENT WITH DRUGS, THE LATER SYMPTOMS WERE ALLEVIATED, AND THE SYMPTOMS SUBSIDED AFTER THREE DAYS, NO PRURITUS RECURRED, THE WOUND HEALED WELL, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Discomfort; Itching Sensation

  MAUDE report 11811589 ↗
• InjuryJan 28, 2021Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2003. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury; Scar Tissue

  MAUDE report 11242936 ↗
• InjuryDec 3, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH LARGE, PRE-SHAPED WITH KEYHOLE ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH LARGE, PRE-SHAPED WITH KEYHOLE. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury; Pain

  MAUDE report 10939604 ↗