BARD 0113700Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741030697), received between Feb 22, 2018 and Sep 24, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Patient-Device Incompatibility

  Patient problems: Pain

  MAUDE report 50889063 ↗
• InjuryNov 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A RIGHT INGUINAL HERNIA REPAIR A PRE-SHAPED MESH WAS PLACED. IT WAS REPORTED THAT AFTER REGAINING CONSCIOUSNESS FROM ANESTHESIA POST IMPLANT, THE PATIENT EXPERIENCED ITCHING AND DISCOMFORT AT THE INCISION SITE. PATIENT WAS PROVIDED ANTI-ALLERGIC MEDICATION TO ASSIST AND THE SYMPTOMS AND ITCHING WERE REDUCED ON THE SAME DAY AFTER TREATMENT. AS REPORTED THE ITCHING AND DISCOMFORT AT THE INCISION SITE REAPPEARED THE NEXT DAY.

  Patient problems: Discomfort; Itching Sensation

  MAUDE report 23473594 ↗
• InjuryMay 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT TENSION-FREE REPAIR PROCEDURE OF UNILATERAL INGUINAL HERNIA WITH IMPLANT OF PRE-SHAPED MESH ON (B)(6) 2024. IT WAS REPORTED THAT PATIENT DEVELOPED INFECTION AT THE INCISION TWO DAYS LATER AND WAS IMMEDIATELY GIVEN INCISIONAL DRAINAGE AND ANTI-INFECTIVE TREATMENT WAS PROVIDED WITH MEDICATIONS. IT WAS REPORTED THAT PATIENT WAS DISCHARGED ON (B)(6) 2024 WITH IMPROVEMENT IN HEALTH STATUS.

  Patient problems: Unspecified Infection

  MAUDE report 19264506 ↗
• InjuryJul 24, 2023Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2008: PATIENT WITH HISTORY OF SMALL BOWEL OBSTRUCTION WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA AND UNDERWENT REPAIR WITH MESH. PER OPERATIVE NOTES, ¿THE INDIRECT SAC WAS DISSECTED FREE AND A MEDIUM PERFIX PLUG (DEVICE #1) WAS PLACED AND SUTURED. THE DIRECT SAC WAS REDUCED, AND A LARGE PERFIX PLUG (DEVICE #2) WAS PLACED AND SUTURED. THE PRE-SHAPED MESH (DEVICE #3) WAS THEN PLACED DOWN AND SUTURED¿. ON (B)(6) 2016: PATIENT VISITED HOSPITAL DUE TO RIGHT LOWER QUADRANT SUBCUTANEOUS NODULE. ON (B)(6) 2016: PATIENT HAD PAIN, DISCOMFORT AND WAS DIAGNOSED WITH RECURRENT RIGHT DIRECT INGUINAL HERNIA WITH DISLODGED MESH PLUG. THE MASS WAS EXTREMELY HARD, THIS WAS MOSTLY LIKELY A FOREIGN BODY FROM PREVIOUS SURGERY. IT APPEARED TO BE A PLUG OF POLYPROPYLENE MESH. THEN THE PERFIX PLUG (DEVICE #2) WAS EXCISED AND DISSECTED AWAY. THIS REVEALED A RECURRENT RIGHT DIRECT INGUINAL HERNIA AND REPAIR WAS COMPLETED¿. (NOTE: THERE WAS NO MENTION OF DEVICE #1 & #3 DURING THE PROCEDURE). ON (B)(6) 2018: PATIENT WAS DIAGNOSED WITH INFECTED FOREIGN BODY WITH SUTURE MATERIAL AND RIGHT UPPER QUADRANT DEEP MUSCLE ABSCESS WITH SINUS TRACT. PER OPERATIVE N

  Patient problems: Unspecified Infection

  MAUDE report 17380648 ↗
• InjuryMay 9, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL LARGE PRE-SHAPED MESH ON (B)(6)2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE LARGE PRE-SHAPED 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: Insufficient Information; Pain

  MAUDE report 16893030 ↗
• InjuryApr 24, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS ALLEGED THAT IN 2012 THE PATIENT WAS IMPLANTED WITH A BARD PRE-SHAPED MESH. AS ALLEGED THE PATIENT HAS BEEN TREATED FOR MULTIPLE INFECTIONS SINCE IMPLANT. THE PATIENT'S DOCTOR IS CULTURING AND PRESCRIBING ANTIBIOTICS FOR THE INFECTIONS.

  Patient problems: Unspecified Infection

  MAUDE report 8545294 ↗
• InjuryJan 31, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2016: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH. THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH. ON (B)(6) 2017: THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE BARD MESH, AND UNDERWENT REVISION SURGERY. THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH. THE 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.¿.

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

  MAUDE report 8294332 ↗
• InjuryOct 23, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2016: THE PATIENT UNDERWENT REPAIR OF BILATERAL INGUINAL HERNIAS. BARD FLAT MESH (DEVICE #1 AND DEVICE #2) WAS IMPLANTED IN PATIENT FOR EACH OF HIS INGUINAL HERNIA REPAIRS. ON (B)(6) 2017: THE PATIENT BEGAN EXPERIENCING CONSTANT BURNING, PAIN, AND EXTREME SENSITIVITY TO TOUCH IN HIS GROIN AREA. HE ALSO BEGAN EXPERIENCING A SENSATION AS THOUGH BROKEN GLASS WAS INSIDE HIS BODY. PATIENT IS BEING TREATED AT A PAIN MANAGEMENT CENTER AND HAS BEEN PRESCRIBED MEDICATION AND HAS RECEIVED NERVE BLOCKS TO TREAT HIS PAIN. HOWEVER, THE MEDICATION AND NERVE BLOCKS HAVE RESULTED IN ONLY MARGINAL IMPROVEMENT. THE PATIENT SUFFERS FROM HIS COMPLICATIONS EVERY DAY. PATIENT'S SYMPTOMS ARE EXACERBATED BY PHYSICAL EXERCISE SUCH AS JOGGING AND OTHER FORMS OF EXERCISE, WHEN THE PAIN AND BURNING SENSATIONS EXTEND UPWARD TO HIS NAVEL AND DOWN INTO HIS UPPER THIGHS. BY THE END OF THE DAY, ANY TYPE OF CLOTHING PATIENT WEARS THAT TOUCHES GROIN AREA, SUCH AS PANTS AND SHORTS, CAUSES HIM PAIN AND DISCOMFORT. THE PATIENT'S HERNIA MESH COMPLICATIONS EITHER PREVENT OR DISCOURAGE HIM FROM ENGAGING IN MANY ACTIVITIES. IT IS PAINFUL FOR PATIENT TO WEAR A S

  Patient problems: Burning Sensation; Deformity/ Disfigurement; Disability; Pain

  MAUDE report 7995305 ↗
• InjuryOct 23, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2016: THE PATIENT UNDERWENT REPAIR OF BILATERAL INGUINAL HERNIAS. BARD FLAT MESH (DEVICE #1 AND DEVICE #2) WAS IMPLANTED IN PATIENT FOR EACH OF HIS INGUINAL HERNIA REPAIRS. ON (B)(6) 2017: THE PATIENT BEGAN EXPERIENCING CONSTANT BURNING, PAIN, AND EXTREME SENSITIVITY TO TOUCH IN HIS GROIN AREA. HE ALSO BEGAN EXPERIENCING A SENSATION AS THOUGH BROKEN GLASS WAS INSIDE HIS BODY. PATIENT IS BEING TREATED AT A PAIN MANAGEMENT CENTER AND HAS BEEN PRESCRIBED MEDICATION AND HAS RECEIVED NERVE BLOCKS TO TREAT HIS PAIN. HOWEVER, THE MEDICATION AND NERVE BLOCKS HAVE RESULTED IN ONLY MARGINAL IMPROVEMENT. THE PATIENT SUFFERS FROM HIS COMPLICATIONS EVERY DAY. PATIENT'S SYMPTOMS ARE EXACERBATED BY PHYSICAL EXERCISE SUCH AS JOGGING AND OTHER FORMS OF EXERCISE, WHEN THE PAIN AND BURNING SENSATIONS EXTEND UPWARD TO HIS NAVEL AND DOWN INTO HIS UPPER THIGHS. BY THE END OF THE DAY, ANY TYPE OF CLOTHING PATIENT WEARS THAT TOUCHES GROIN AREA, SUCH AS PANTS AND SHORTS, CAUSES HIM PAIN AND DISCOMFORT. THE PATIENT'S HERNIA MESH COMPLICATIONS EITHER PREVENT OR DISCOURAGE HIM FROM ENGAGING IN MANY ACTIVITIES. IT IS PAINFUL FOR PATIENT TO WEAR A S

  Patient problems: Burning Sensation; Deformity/ Disfigurement; Disability; Pain

  MAUDE report 7995301 ↗
• InjuryAug 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED VIA (B)(4): THE PATIENT WAS IMPLANTED WITH A DAVOL PRE-SHAPLED MESH AND EXPERIENCED A POSTOPERATIVE NON-HEALING WOUND. AS REPORTED ANTI-INFECTIVE THERAPY ADMINISTERED.

  Patient problems: Impaired Healing

  MAUDE report 7836607 ↗
• InjuryAug 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED VIA CFDA (CHINA FOOD AND DRUG ADMINISTRATION): ON (B)(6) 2017, THE PATIENT HAD A TENSION-FREE REPAIR OF A RIGHT OBLIQUE HERNIA. DURING THIS PROCEDURE THE PATIENT WAS IMPLANTED WITH A DAVOL PRE-SHAPED MESH. THE SURGICAL PROCEDURE WENT SMOOTH. ON (B)(6) 2017 AN INCISION INFECTION WAS IDENTIFIED AND ALLEGED TO BE RELATED TO THE HERNIATION PATCH. THE PATIENT UNDERWENT A PROCEDURE TO OPEN THE WOUND, STRENGTHEN DRESSING AND APPLY ANTI-INFECTIVE TREATMENT. THE WOUND SECRETION WAS SENT FOR EXAMINATION AND CULTURE OF STAPHYLOCOCCUS AUREUS, II SUTURE WOUND.

  Patient problems: Bacterial Infection

  MAUDE report 7832530 ↗
• InjuryAug 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED VIA (B)(6)): ON (B)(6) 2017, THE PATIENT HAD A TENSION-FREE REPAIR OF THE RIGHT GROIN UNDER EPIDURAL ANESTHESIA. DURING THIS PROCEDURE THE PATIENT WAS IMPLANTED WITH A DAVOL PRE-SHAPED MESH. AS REPORTED THE SURGICAL PROCEDURE WENT SMOOTH. ON (B)(6) 2017 AN INCISION INFECTION WAS IDENTIFIED AND THE PATIENT UNDERWENT A PROCEDURE TO OPEN THE WOUND, STRENGTHEN DRESSING AND APPLY ANTI-INFECTIVE TREATMENT. WOUND SECRETION WAS SENT FOR EXAMINATION AND CULTURE.

  Patient problems: Bacterial Infection

  MAUDE report 7826417 ↗
• InjuryAug 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED VIA CFDA ((B)(4) FOOD AND DRUG ADMINISTRATION): DUE TO A RIGHT OBLIQUE HERNIA ON (B)(6) 2017 THE PATIENT UNDERWENT HIGH LIGATION AND TENSION-FREE REPAIR. A DAVOL PRE-SHAPED MESH WAS USED FOR THE REPAIR. ON (B)(6) 2017 EXUDATION OF THE WOUND WAS NOTED. THE PATIENT WAS TREATED WITH SYSTEMIC ANTIBIOTICS (BASED ON DRUG ALLERGY) AND LOCAL DRESSING CHANGES. ON (B)(6) 2017 THE PATIENT UNDERWENT EXPLANT OF THE MESH AND WAS DISCHARGED ON (B)(6) 2017.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 7824166 ↗
• InjuryFeb 22, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. A BARD/DAVOL FLAT MESH, REFERENCE NUMBER 0113700, LOT NUMBER HUUF1260 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2012: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR RECURRENCE REPAIR. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE MARLEX.

  Patient problems: Abdominal Pain; Disability; Hernia; Pain

  MAUDE report 7288392 ↗