BARD 0112710Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00801741016554), received between Sep 25, 2017 and Apr 10, 2026 — classified as 62 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (55 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 63 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Patient-Device Incompatibility

  AS PER (B)(4): DATE OF OCCURRENCE: (B)(6) 2025. AS REPORTED, ON (B)(6) 2025 THE PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR WITH THE IMPLANT OF BARD PRE-SHAPED MESH. DESCRIPTION OF THE INCIDENT: "INCREASING PAIN AT THE SCAR SITE, WHICH IS STILL HARDENED, NOTICED DURING THE PHARMACIST¿S DAILY ACTIVITIES STANDING STILL, RESUMING WALKING AFTER SITTING DOWN, SENSATION OF WARMTH. DESPITE A BUSY WORK SCHEDULE, I CANNOT SHAKE OFF THE PAIN." REASON FOR ADMISSION: RIGHT INGUINAL HERNIA. SUMMARY OF STAY: CONCLUSION OF PROCEDURES AND EXAMINATIONS: REPAIR USING A PROSTHETIC MESH PERFORMED UNDER GOOD CONDITIONS AND WITHOUT COMPLICATIONS. PATIENT¿S CLINICAL CONDITION ON DISCHARGE: THE PATIENT¿S CLINICAL CONDITION IS SATISFACTORY AND PERMITS MEDICAL DISCHARGE TODAY. AS PER THE REPORT OF ULTRASOUND OF THE RIGHT INGUINAL REGION DATED (B)(6) 2026: REASON FOR THE EXAMINATION: FOLLOW-UP OF A SCAR FOLLOWING SURGERY IN SEPTEMBER 2025 FOR A RIGHT INGUINAL HERNIA, WITH PERSISTENT DISCOMFORT AND TINGLING PAIN AT THE SCAR SITE. NO BOWEL DYSFUNCTION OR FEVER. CONCLUSION: NO ABNORMALITIES DETECTABLE ON ULTRASOUND OF THE RIGHT INGUINAL SCAR AREA. IF PAINFUL SYMPTOMS PERSIST, A FURTHER CT SCAN COULD BE PERFO

  Patient problems: Discomfort; Implant Pain

  MAUDE report 24839919 ↗
• InjuryApr 3, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM REPORT (B)(4) IN SUMMARY: DESCRIPTION OF THE INCIDENT: FOLLOWING ABDOMINAL PAIN AND SWELLING IN THE RIGHT GROIN, THE PATIENT UNDERWENT SURGERY ON (B)(6) 2022 WITH THE IMPLANTATION OF BARD PRE-SHAPED MESH, FOR A RIGHT INDIRECT INGUINAL HERNIA USING THE LICHTENSTEIN TECHNIQUE. CLINICAL CONSEQUENCES AND CURRENT STATUS: "SINCE UNDERGOING THIS SURGERY IN 2022, I HAVE BEEN SUFFERING FROM CHRONIC, DEBILITATING NEUROPATHIC PAIN, INCLUDING NEURALGIA, ALGODYSTROPHY OF THE RIGHT BIG TOE, AND ALLODYNIA. PAIN IN THE RIGHT TESTICLE. PAIN IN THE INNER RIGHT THIGH. INJURIES TO THE ILIOINGUINAL, ILIOHYPOGASTRIC, AND GENITOFEMORAL SENSORY NERVES. PAIN IN THE PUBIC REGION, PUBIS, SCAR AREA, AND RADIATING TOWARD THE BACK. SINCE ON (B)(6) 2023, I HAVE BEEN UNDER THE CARE OF THE PAIN MANAGEMENT, WHERE SEVERAL TREATMENTS HAVE BEEN IMPLEMENTED BY THE MULTIDISCIPLINARY TEAM, SEVERAL SESSIONS OF QUTENZA PATCHES IN THE OUTPATIENT DEPARTMENT. TEENS. ABOUT TWENTY KETAMINE INFUSIONS ON AN OUTPATIENT BASIS. TWO SESSIONS OF PULSED RADIOFREQUENCY THERAPY. I'M ALSO ON A FAIRLY STRONG MEDICATION: 120 MG OF CYMBALTA A DAY. 300 MG OF TRILEPTAL PER DAY. 2 VERSATIS PATCHES PER NIGHT/DAY. 13 DROPS OF

  Patient problems: Constipation; Dysuria; Hyperesthesia; Nerve Damage; Neuralgia; Pain

  MAUDE report 24778577 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  AS REPORTED VIA ANSM REPORT ((B)(4)): ON (B)(6) 2022 THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR WITH THE IMPLANT OF BARD PRE-SHAPED MESH. DATE OF OCCURRENCE: (B)(6) 2022. DESCRIPTION OF THE INCIDENT: "SEVERAL EPISODES OF DISCOMFORT IN THE DAYS FOLLOWING THE PROCEDURE, SEVERE PAIN, INABILITY TO WALK. COMMENTS: LITTLE IMPROVEMENT FOLLOWING THE PROCEDURE, PAIN DURING EVEN THE SLIGHTEST EXERTION, DIFFICULTIES PERFORMING MY JOB. PAIN WORSE THAN BEFORE THE SURGERY" TYPE OF SURGERY: LEFT INGUINAL HERNIA REPAIR CURRENT PATIENT STATUS: REGULAR PAIN AT THE SITE OF THE SURGERY ACTIONS TAKEN BY THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

  MAUDE report 24700319 ↗
• InjuryFeb 14, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCARCERATED RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1) AND PRE-SHAPED MESH (DEVICE 2). PER OP NOTES, "AN INCISION WAS MADE IN THE RIGHT INGUINAL AREA, A PERFIX PLUG (DEVICE 1) AND A BARD MESH PRE-SHAPED (DEVICE 2) WERE PLACED USING PROLENE SUTURES." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR. PER OP NOTES, "THE SPERMATIC CORD WAS DENSELY ADHERENT TO THE SURROUNDING STRUCTURES. THE MESH WAS INVOLVED IN SCAR AND CHRONIC INFLAMMATORY TISSUE; A SYNTHETIC MESH WAS PLACED."

  Patient problems: Adhesion(s); Hernia; Inflammation

  MAUDE report 24340536 ↗
• InjuryJun 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2005 - PATIENT WAS DIAGNOSED BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD MESH PRE-SHAPED WITH KEYHOLE (DEVICE #1, #2). PER OPERATIVE NOTES, "ON RIGHT SIDE, A DIRECT HERNIA WAS NOTED AND A BARD MESH PRE-SHAPED WITH KEYHOLE (DEVICE #1) WAS SUTURED. ON RIGHT SIDE, A LARGE DIRECT HERNIA. A BARD MESH PRE-SHAPED WITH KEYHOLE (DEVICE #2) WAS PLACED AND SUTURED." ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH BILATERAL GROIN PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF MESHES (DEVICE #1, #2) AND IMPLANT OF BARD SOFT MESH (DEVICE #3, #4). PER OPERATIVE NOTES, "ON RIGHT SIDE, A BARD SOFT MESH (DEVICE #3) AND TACKED. SAME PROCEDURE WAS DONE ON THE LEFT SIDE WITH BARD SOFT MESH (DEVICE #4) TACKED IN MIDLINE. THE MESH WAS DENSELY ADHERENT TO THE NERVES. THE ILIOINGUINAL, GENITOFEMORAL NERVES WERE RESECTED. THE MESH (DEVICE #1, #2) WAS REMOVED."

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

  MAUDE report 22163691 ↗
• InjuryJan 31, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A VERY LARGE UMBILICAL HERNIA WAS IDENTIFIED. A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ ON (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PRESHAPED MESH W/ KEYHOLE (DEVICE #2). PER OPERATIVE NOTES, ¿A LARGE SCLEROTIC SAC WAS DISSECTED, AND A PRESHAPED MESH W/ KEYHOLE (DEVICE #2) WAS SEWN IN PLACE AT THE PUBIC TUBERCLE AND SUTURED.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION, ADHESIONS AND PAIN THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE OMENTUM WAS STUCK UP TO THE MESH. THIS WAS TAKEN DOWN METICULOUSLY, AND THIS COMPLETELY RELIEVED THE OBSTRUCTION.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿THE ADHESIONS WERE TAKEN DOWN AND A SYNTHETIC MESH WAS SECURED CIRCUMFERENTIALLY USING SUTURES.¿ (THERE WAS NO VISUALIZATION/MENTION OF PRESHAPED MESH W/ KE

  Patient problems: Adhesion(s); Hernia; Seroma

  MAUDE report 21282061 ↗
• InjuryJun 24, 2024Defective 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 (X2) AND BARD PRE-SHAPE/KEYHOLE MESH (X2) ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG (X2) AND BARD PRE-SHAPE/KEYHOLE MESH (X1). 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 19593295 ↗
• InjuryFeb 15, 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/DAVOL 3DMAX LIGHT ON (B)(6) 2016 AND BARD MESH (BARD FLAT MESH) ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. 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

  MAUDE report 18709869 ↗
• MalfunctionNov 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING PLACEMENT OF THE PRE-SHAPED MESH, THE SUTURE USED TO FIX THE PLATE (MESH) TEARS THE PLATE (MESH). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220435 ↗
• InjuryJul 6, 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) 2019. 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: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 14926208 ↗
• InjuryJul 5, 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 PRESHAPED KEYHOLE ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD PRESHAPED 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: Hernia; Insufficient Information; Pain

  MAUDE report 14917285 ↗
• InjuryJun 24, 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/DAVOL MARLEX (BARD FLAT MESH) ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST MARLEX (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; Insufficient Information

  MAUDE report 14797035 ↗
• InjuryMay 10, 2022Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH PRE-SHAPED WITH KEYHOLE ON (B)(6) 2002. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH 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: Hernia; Insufficient Information

  MAUDE report 14345332 ↗
• InjuryMar 20, 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/DAVOL MARLEX (BARD FLAT MESH) ON (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MARLEX (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED UNSPECIFIED INJURY 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; Pain

  MAUDE report 13829640 ↗
• InjuryFeb 5, 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) 2006. 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 UNDERWENT REMOVAL OF HERNIA MESH ON (B)(6) 2007. 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: Inflammation; Insufficient Information; Nerve Damage; Pain; Scar Tissue

  MAUDE report 13466849 ↗
• InjuryDec 6, 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 AN UNSPECIFIED BARD MESH (BARD FLAT MESH) (X3) ON (B)(6) 2000 (X2) AND (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BARD MESH (BARD FLAT MESH) (X2). 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; Pain

  MAUDE report 12934398 ↗
• InjuryDec 6, 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 AN UNSPECIFIED BARD MESH (BARD FLAT MESH) (X3) ON (B)(6) 2000 (X2) AND (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BARD MESH (BARD FLAT MESH) (X2). 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: Adhesion(s); Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 12934259 ↗
• InjuryNov 19, 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 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 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; Seroma

  MAUDE report 12843939 ↗
• InjuryJul 18, 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 UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL PERFIX PLUG ON (B)(6) 2015 (X2). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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 12186529 ↗
• InjuryApr 13, 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 AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2019. 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

  MAUDE report 11656121 ↗
• InjuryApr 9, 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 AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2012. 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." ATTORNEY ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 11642407 ↗
• InjuryMar 31, 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 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 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

  MAUDE report 11599055 ↗
• InjuryDec 9, 2020Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2013. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RIGHT FEMORAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD MESH PRE-SHAPED W/ KEYHOLE. PER OPERATIVE NOTES, ¿THE HERNIA DEFECT WAS IDENTIFIED AND DISSECTED. A BARD MESH PRE-SHAPED W/ KEYHOLE MESH WAS PLACED AND SUTURED. ¿ (B)(6) 2017 - PATIENT HAD GROIN PAIN AND WAS DIAGNOSED WITH INCARCERATED, STRANGULATED AND PERFORATED RIGHT FEMORAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REDUCTION OF HERNIA WITH SMALL BOWEL RESECTION. PER OPERATIVE NOTES, ¿THE NECROTIC, STRANGULATED AND INCARCERATED HERNIA SAC WAS IDENTIFIED AND DISSECTED FREE. PERFORAT

  Patient problems: Bowel Perforation; Disability; Hernia; Injury; Necrosis; Pain; Strangulation

  MAUDE report 10975504 ↗
• InjuryNov 20, 2020Defective 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) 2019. 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: Disability; Hernia; Injury; Nerve Damage; Pain

  MAUDE report 10874999 ↗
• InjuryOct 29, 2020Defective 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) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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: Disability; Hernia; Injury; Pain

  MAUDE report 10754293 ↗