BARD 0117009Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741030864), received between Sep 14, 2015 and Jun 29, 2026 — classified as 38 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (25 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011- PATIENT WAS DIAGNOSED WITH LARGE INCARCERATED LEFT INGUINAL HERNIA, LARGE DEFECT IN LEFT LOWER QUADRANT, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 1, 2, 3, 4, 5, 6), BARD SOFT MESH (DEVICE 7). PER OP NOTES, "A LARGE HERNIA NOTED AND PALPABLE IN THE LEFT GROIN WITH OMENTUM IN LEFT HEMISCOTUM. A LARGE HERNIA DEFECT IN LEFT LOWER QUADRANT WITH HERNIAS IN THE FLOOR OF LEFT INGUINAL CANAL. AN INDIRECT HERNIA WAS ALSO NOTED IN THE LEFT INGUINAL REGION. THERE WERE LARGE DIRECT AND INDIRECT HERNIAS IN THE FLOOR OF LEFT INGUINAL AREA. THESE HERNIA SACS WERE CAREFULLY DISSECTED. THE HERNIA CONTENTS WERE REDUCED. AN EXTRA-LARGE PERFIX PLUGS (DEVICE 1, 2, 3, 4, 5, 6) WERE SUPERIORLY TO THE CONJOINED TENDON AND WERE SUTURED TOGETHER. ANOTHER HERNIA IN FLOOR OF THE LEFT INGUINAL REGION WAS IDENTIFIED AND REPAIRED BY PLACING A BARD SOFT MESH (DEVICE 7) AND SUTURED." ON (B)(6) 2016- PATIENT HAD ABDOMINAL PAIN. ON (B)(6) 2018- PATIENT HAD HERNIA REPAIR. ON (B)(6) 2021- PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, PAIN, THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH EXPLANT OF PERFIX PLUGS (DEVICE 1, 2, 3,

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 25657715 ↗
• InjuryApr 8, 2026Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH MULTIPLE RECURRENT VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1). PER OP NOTES, ¿AN LEFT SUBCOASTAL INCISION WAS MADE. RECURRENT VENTRAL HERNIA WITH THE MESH SEPARATED FROM THE LEFT SUPERIOR SIDE WAS NOTED. MOST OF THE PRIOR MESH WAS WELL INCORPORATED BUT THE PART NEAR THE RECURRENCE WAS FREE AND REMOVED. THEN UNDERLAY REPAIR WAS PERFORMED BY PLACING A VENTRALIGHT ST MESH (DEVICE 1) FACING THE ABDOMINAL VISCERA AND SECURED TO THE FASCIA WITH SUTURE.¿ (NOTE: THE PRIOR MESH VISUALIZED DURING THIS PROCEDURE WAS UNKNOWN) ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST MESH (DEVICE 1) AND IMPLANT OF BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿THE PREVIOUS MIDLINE WOUND WAS OPENED. ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WERE FREED. THE PRIOR MESH (DEVICE 1) WAS REMOVED. SEPRAFILM WAS PLACED UNDER THE ABDOMINAL CLOSURE. THE ABDOMINAL WALL WAS THEN CLOSED WITH SUTURES. A BARD SOFT MESH (DEVICE 2) WAS PLACED AND SECURED TO THE FASCIA WITH SUTURE.¿ ON (B)(6) 2020 - PATIENT WAS DIAGN

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 24813428 ↗
• InjuryMar 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL HERNIA PATCHES (DEVICE 1 AND 2). PER OP NOTES, ¿ON THE RIGHT INGUINAL REGION, THE HERNIA DEFECTS WERE NOTED AND REDUCED. A KUGEL HERNIA PATCH (DEVICE 1 - RIGHT) WAS PLACED AND SUTURED. ON THE LEFT INGUINAL REGION, A LARGE HERNIA DEFECT WAS NOTED WITH PERITONEAL FAT WERE REDUCED. A KUGEL HERNIA PATCH (DEVICE 2 - LEFT) WAS PLACED AND SUTURED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF KUGEL HERNIA PATCH (DEVICE 2), IMPLANT OF 3DMAX (DEVICE 3) AND BARD SOFT MESH (DEVICE 4). PER OP NOTES, ¿PREVIOUS LEFT GROIN INCISION WAS OPENED. THE SCAR TISSUE WAS EXCISED. THE PRIOR MESH (DEVICE 2) WAS NOTED ROLLED UP WAS EXCISED AND REMOVED. THE RECURRENT HERNIA IS ON THE LATERAL SIDE OF OLD MESH. THE HERNIA WAS REDUCED. ADHESIONS WERE LYSED. A 3DMAX (DEVICE 3) WAS PLACED IN THE PREPERITONEAL SPACE AND SUTURED. A BARD SOFT MESH (DEVICE 4) WAS PLACED AS OVERLAP AND SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH ABSCESS AND INFECTED LEFT GROIN MESH THEREBY UNDERWENT OPEN REPAIR

  Patient problems: Abscess; Adhesion(s); Fistula; Hernia; Seroma; Unspecified Infection

  MAUDE report 24493753 ↗
• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, "A MIDLINE INCISION WAS MADE FROM ABOVE THE UMBILICUS DOWN TO BELOW THE UMBILICUS OVER THE HERNIA SAC. A BARD FLAT MESH (DEVICE 1) WAS SUTURED TO THE FASCIA USING PROLENE SUTURES." (B)(6) 2013 - PATIENT HAD SEPSIS. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF BARD SOFT MESH (DEVICE 2). PER OP NOTES, "MIDLINE INCISION MADE THROUGH THE PREVIOUS SCAR. REMOVAL OF THE OLD MESH (DEVICE 1) FROM THE UMBILICAL AREA, A BARD SOFT MESH (DEVICE 2) WAS SUTURED TO THE RECTUM SHEATH USING PROLENE SUTURES." (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA AND HAD ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX ST (DEVICE 3). PER OP NOTES, "INCISION WAS CARRIED DOWN THROUGH SUBCUTANEOUS TISSUE TO WHERE THE MESH AND FASCIA WAS LOCATED. A PHASIX ST (DEVICE 3) WAS PLACED USING SUTURES."

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 24457024 ↗
• InjuryFeb 18, 2026Material Deformation; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA AND INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD SOFT MESH (DEVICE 1) AND VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿ AN INCARCERATED LARGE RIGHT INDIRECT INGUINAL HERNIA ADHESED TO CECUM AND APPENDIX WERE NOTED. THE HERNIA DEFECT WAS REDUCED AND ADHESIONS WERE TAKEN DOWN. A PIECE OF BARD SOFT MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND ANCHORED TO THE PERITONEUM WITH SUTURES AND STAPLES. A SMALL MIDLINE INCISIONAL HERNIA SUPERIOR TO THE UMBILICUS WAS REDUCED AND ADHESIONS BETWEEN OMENTUM AND PERITONEUM WERE DIVIDED. THE DEFECT WAS CLOSED AND MEDIUM SIZED VENTRALEX ST MESH (DEVICE 2) WAS PLACED OVER THE DEFECT AND SECURED IN PLACE WITH TACKS AND SUTURES.¿ ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿ IN THE RIGHT SIDE, INGUINAL DEFECT CONTAINING BOWEL WAS NOTED. THERE WAS A SCARRING FROM PRIOR SURGERY THAT ADHERED TO COLON AND HERNIA DEFECT. THE MESH (DEVICE 1) WAS BUCKLED UP AND SEPARATED FROM THE SUPERIOR BORDER. THE HERNIA D

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

  MAUDE report 24377141 ↗
• MalfunctionJan 22, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, ON (B)(6) 2025 DURING A PROCEDURE PRIOR TO OPENING THE BARD SOFT MESH PACKAGE, A SMALL FIBER/HAIR WAS NOTICED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146448 ↗
• InjuryJun 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, POST IMPLANT OF SOFT MESH, THE PATIENT HAD MULTIPLE INFECTIONS, HEMATOMA AND WOUND THAT WOULD NOT HEAL. IT IS REPORTED THAT THE HERNIA WAS ¿OUTSIDE THE BODY NOW.¿ THE PATIENT WAS IN AND OUT OF THE HOSPITAL AND WOUND CARE DAILY¿ AND WAS TREATED WITH MULTIPLE ANTIBIOTICS. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REMOVAL SURGERY ON (B)(6) 2024. THE PATIENT HAS BEEN REFERRED TO A SPECIALIST TO REMOVE THE MESH AS THE IMPLANTING SURGEON SAID, ¿SHE CANNOT REMOVE THE MESH WITHOUT INJURING HIS ABDOMINAL WALL.¿ REPORTEDLY, THE PATIENT IS AWAITING AN APPOINTMENT WITH THE SPECIALIST TO DISCUSS MESH REMOVAL.

  Patient problems: Hematoma; Hernia; Impaired Healing; Unspecified Infection

  MAUDE report 19479943 ↗
• InjuryMay 1, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ABOUT 90 DAYS AGO PATIENT UNDERWENT HERNIORRHAPHY SURGERY TO REPAIR PARAUMBILICAL HERNIA WITH THE IMPLANT OF SOFT MESH ABOVE THE ABDOMINAL WALL MUSCLES. IT WAS REPORTED THAT POST OPERATIVELY, THE PATIENT WAS OKAY, BUT 2 WEEKS AGO PATIENT HAD REDNESS AND SMALL PAPULAR DISCHARGE, EXTENDED OVER THE ABDOMINAL WALL. IT WAS REPORTED THAT PATIENT WAS PRESCRIBED WITH ANTI-INFLAMMATORY, ANTI-HISTAMINIC AND ANTIBIOTICS WITH NO IMPROVEMENT.

  Patient problems: Erythema; Rash

  MAUDE report 19221569 ↗
• 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: Insufficient Information; Pain

  MAUDE report 19078025 ↗
• InjuryMar 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH BARD SOFT MESH. IT WAS REPORTED THAT THE PATIENT DEVELOPED A SUPERFICIAL SURGICAL SITE INFECTION WITH STAPHYLOCOCCUS AUREUS ON (B)(6) 2024 THEREBY, UNDERWENT SURGERY FOR INCISION AND DRAINAGE, DEBRIDEMENT, REMOVAL OF MESH AND TREATED WITH IV VANCOMYCIN. PATIENT WAS DISCHARGED WITH WET TO DRY DRESSING CHANGES.

  Patient problems: Bacterial Infection

  MAUDE report 18846988 ↗
• InjuryFeb 12, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿MULTIPLE HERNIA DEFECTS WERE IDENTIFIED AND A VENTRIO MESH WAS PLACED TO CONNECT THE DEFECT AND SUTURED.¿ (B)(6) 2011 - PATIENT UNDERWENT COLONOSCOPY. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA, CHRONIC ABDOMINAL PAIN AND DIVERTICULITIS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD SOFT MESH (DEVICE #2) AND EXPLANT OF PREVIOUSLY PLACED MESH. PER OPERATIVE NOTES, ¿A LYSIS OF ADHESIONS WAS PERFORMED TO FREE THE SMALL BOWEL AND COLON THAT WERE ADHERED TO THE PRIOR MESH. THE PREVIOUS MESH (DEVICE #1) WAS COMPLETELY REMOVED. THEN THE HERNIA WAS REPAIRED WITH BARD SOFT MESH (DEVICE #2) OVER THE DEFECTS.¿. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL HERNIA AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR THEREBY UNDERWENT REPAIR. PER OPERATIVE NOTES, ¿THERE WAS EXTENSIVE ADHESIVENESS OF THE INTESTINE TO THE ABDOMINAL WALL, AND IT WAS LYSED. IDENTIFIED A SIGNIFICANT DESEROSALIZATION AND A PERFORATION THAT WE THOUGHT WAS NOT ABLE TO BE REPAI

  Patient problems: Abdominal Pain; Adhesion(s); Bowel Perforation; Fibrosis; Hernia; Seroma

  MAUDE report 18684386 ↗
• InjuryDec 29, 2023Defective 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 SOFT MESH ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD SOFT 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: Abscess; Cellulitis; Insufficient Information; Pain

  MAUDE report 18417308 ↗
• MalfunctionAug 17, 2023Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2023, AN EXPIRED BARD SOFT MESH WAS INADVERTENTLY IMPLANTED INTO THE PATIENT. THE LABELED EXPIRATION DATE OF THE IMPLANT IS (B)(6) 2022. THERE WAS NO ADDITIONAL MEDICAL TREATMENT PROVIDED AND THE SURGEON HAS NO CONCERN FOR ADDITIONAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564817 ↗
• MalfunctionDec 9, 2021Material Integrity Problem; Material Integrity Problem

  AS REPORTED DURING AN OPEN INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, THE BARD SOFT MESH WAS CUT TO SIZE WITH CURVED MAYO SCISSORS. AS REPORTED "THE CROSS SECTIONS WERE STICKING OUT POKING INTO THE TISSUE. THIS WAS FELT AS A SAFETY CONCERN BY THE PHYSICIAN THAT THIS ¿JAGGED¿ EDGE COULD POTENTIALLY DAMAGE NERVES IN THE AREA OR THE TISSUE." AS REPORTED, THE SIZE OF THE MESH AFTER BEING CUT IS NOT KNOWN. IT WAS REPORTED THAT THE MESH WAS USED AND REMAINS IMPLANTED IN THE PATIENT. AS REPORTED, THERE WAS NO PATIENT INJURY AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12970678 ↗
• InjuryNov 5, 2020Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5096812): ALLERGIC MESH REACTION DESTROYING MY QOL. TWO DEVICES; COLOPLAST ALTIS URETHRA SLING AND BARD SOFT MESH FOR SACROCOLPOPEXY. COLOPLAST ALTIS SLING AT ONE WEEK POST OP INITIATED REPEATED UTI, PAIN AND GAIT DISTURBANCE, WHERE NONE EXISTED BEFORE. REMOVAL OF MESH REQUIRED TRAVEL TO ANOTHER STATE AT ONE MONTH POST OP FOR SURGERY AND STOPPED UTI BUT SOME URINE RETENTION AND DISCOMFORT REMAIN. STILL TESTING FOR DAMAGE AND POSSIBLE PUDENDAL NERVE ENTRAPMENT. SUCCESSFUL REMOVAL OF THE ANCHORS REQUIRED TRAVEL FOR A SECOND REMOVAL SURGERY AT 13 MONTHS POST OP AT A SPECIALIST IN (B)(6) CLINIC IN (B)(6) FROM ANOTHER STATE. ALTHOUGH BOTH ANCHORS WERE FOUND AND REMOVED, THE ANCHORS ARE NOT ALWAYS FOUND AND FEW SURGEONS WILL ATTEMPT IT. THIS SURGERY REQUIRES THIGH DISSECTION. BY THE WAY, MY SURGEON DID NOT DISCUSS THE SLING SURGERY WITH ME. HE KNEW I HAD NO URINARY INCONTINENCE. I DID NOT KNOW I WAS SCHEDULED FOR URINARY SLING SURGERY. PREVIOUSLY HE CANCELLED MY SURGERY BECAUSE I HAD QUESTIONS, SO I COULDN'T ASK ABOUT THE SURGERY UNLESS I TOOK THE RISK OF HAVING IT CANCEL AGAIN. THE SACROCOLPOPEXY MESH HAS CREATED EXTREMELY DISABLING P

  Patient problems: Ambulation or Postural Difficulties; Disability; Foreign Body Reaction; Inflammation; Tachycardia

  MAUDE report 10790541 ↗
• MalfunctionJul 22, 2020Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, PRIOR TO THE USAGE OF THE SOFT MESH IT WAS FOUND THAT THE INNER POUCH IN DIRECT CONTACT WITH THE MESH WAS NOT SEALED. THERE WAS NO DAMAGE TO THE OUTER SHIPPING BOX AND INNER PRODUCT CARTON OR FOIL POUCH PRIOR TO OPENING. THE PRODUCT WAS DISCARDED AND THE PROCEDURE WAS COMPLETED USING ANOTHER PIECE OF SOFT MESH. AS REPORTED, THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310826 ↗
• InjurySep 12, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE AND WAS IMPLANTED WITH A BARD/DAVOL SOFT MESH. AS REPORTED IN 2016 THE PATIENT WENT TO URGENT CARE DUE TO "EXTREME PAIN" IN THE AREA OF THE HERNIA REPAIR THAT "BROUGHT HIM TO HIS KNEES." AT THIS TIME THE DOCTOR SUSPECTED A HERNIA RECURRENCE BUT THE SURGEON FOUND NO HERNIA. ON (B)(6) 2019 THE PATIENT UNDERWENT SURGERY TO REPAIR A RECURRENT HERNIA. THE SOFT MESH WAS NOT REMOVED AND ANOTHER, UNSPECIFIED MESH WAS PLACED ON TOP. AS REPORTED THE SURGEON TOLD THE PATIENT THAT THE SOFT MESH HAD "FAILED" BUT COULD NOT BE REMOVED AS IT HAD GROWN INTO THE TISSUES. ON (B)(6) 2019 THE PATIENTS POSTOPERATIVE FOLLOW UP FINDS THE WOUND HEALING AS EXPECTED WITH NO FURTHER COMPLICATIONS.

  Patient problems: Hernia; Pain

  MAUDE report 9005599 ↗
• InjuryJul 8, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY, MEDICAL RECORDS & PRODUCT ID PAGE: ON (B)(6) 2011 THE PATIENT WAS DIAGNOSED WITH PELVIC ORGAN PROLAPSE AND UNDERWENT A ROBOTIC ASSISTED SACROCOLPOPEXY WITH IMPLANT OF A BARD/DAVOL SOFT MESH FOLLOWED BY CYSTOSCOPY. ABOUT 4 MONTHS LATER ON (B)(6) 2011 THE PATIENT HAD A POST OP VISIT AND REPORTED A VAGINAL BULGE. PATIENT WAS EXAMINED AND WAS DIAGNOSED WITH A RECTOCELE. PATIENT WAS RECOMMENDED AN ADDITIONAL OUTPATIENT PROCEDURE FOR REPAIR.

  Patient problems: Prolapse

  MAUDE report 8769162 ↗
• InjuryJan 3, 2019Defective Device; No Apparent Adverse Event; Defective Device; No Apparent Adverse Event

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2013:THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH (2) (DEVICE #1 AND DEVICE #2). ON (B)(6) 2017: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SOFT MESH (DEVICE #3). THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S) (DEVICE #1,DEVICE #2 AND DEVICE #3). THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX LIGHT MESH (DEVICE #1 AND DEVICE #2) AND SOFT MESH (DEVICE #3). THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICES WERE DEFECTIVE.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 8214398 ↗
• InjuryAug 20, 2018Defective Device; Defective Device

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT WAS DIAGNOSED WITH RECURRENT PELVIC PROLAPSE, URINARY HESITANCY WITH RETENTION AND UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY WITH IMPLANT OF A BARD/DAVOL BARD SOFT MESH FOLLOWED BY CYSTOSCOPY. ATTORNEY ALLEGES UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED WITH USE OF DEVICE.

  Patient problems: No Information

  MAUDE report 7799459 ↗
• InjuryMay 24, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 1988 - THE PATIENT HAD A PREVIOUS VAGINAL SLING (UNKNOWN) IMPLANTED. ON (B)(6) 2009 - THE PATIENT WAS DIAGNOSED WITH A CYSTOCELE AND UNDERWENT AN ANTERIOR REPAIR WITH IMPLANT OF A BARD/DAVOL SOFT MESH AND A TRANSOBTURATOR TAPE USING A NON-BARD/DAVOL "DESARA" SLING FOLLOWED BY CYSTOSCOPY. ATTORNEY ALLEGES UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED WITH USE OF DEVICE.

  Patient problems: No Information

  MAUDE report 7542456 ↗
• InjuryMay 24, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2012 - THE PATIENT WAS DIAGNOSED WITH A VAGINAL PROLAPSE AND UNDERWENT A VAGINECTOMY AND A TVT RETROPUBIC URETHROPEXY WITH IMPLANT OF A BARD/DAVOL SOFT MESH. ATTORNEY ALLEGES UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED WITH USE OF DEVICE.

  Patient problems: No Information

  MAUDE report 7542268 ↗
• InjuryMar 6, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING IS BASED ON A REVIEW OF LIMITED MEDICAL RECORDS AND THE ATTORNEY'S LEGAL CLAIM PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT UNDERWENT AN UNSPECIFIED PELVIC PROCEDURE WITH IMPLANT OF A BARD/DAVOL SOFT MESH AND A NON-BARD/DAVOL "MONARC" SUBFASCIAL SLING. ATTORNEY ALLEGES UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED WITH USE OF DEVICE.

  Patient problems: Erosion; No Information; Prolapse; Unspecified Infection

  MAUDE report 7315829 ↗
• InjuryJan 8, 2018Defective Device; Defective Device

  THE FOLLOWING IS BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2010 - THE PATIENT WAS DIAGNOSED WITH VAGINAL PROLAPSE, STRESS URINARY INCONTINENCE, URETHRAL MOBILITY, FREQUENCY AND URGENCY. THE PATIENT UNDERWENT A SACROCOLPOPEXY WITH IMPLANT OF A BARD SOFT MESH AND A NON-BARD DAVOL "MONARC" URETHRAL SLING. (B)(6) 2012 - THE PATIENT WAS DIAGNOSED WITH BLADDER FOREIGN BODY, ABDOMINAL ADHESIONS, STRESS URINARY INCONTINENCE AND VAGINAL PROLAPSE. THE PATIENT UNDERWENT ABDOMINAL EXPLORATION, LYSIS OF ADHESIONS, REVISION/REMOVAL OF THE BARD SOFT MESH AND REVISION OF THE NON-BARD DAVOL MID-URETHRAL SLING. PER THE OPERATIVE INDICATION " THE PATIENT IS A (B)(6) FEMALE WHO IS STATUS POST ABD SACROCOLPOPEXY, WHO WAS HAVING RECURRENT URINARY TRACT INFECTIONS AND ABD DISCOMFORT UNDERWENT CYSTOSCOPY. OFFICE CYSTOSCOPY DEMONSTRATED AN AREA ON THE RIGHT LATERAL WALL, WHERE WITHIN THE BLADDER MUCOSA YOU COULD SEE FILAMENTS OF THE MESH THAT WAS USED FOR HER COLPOPEXY AND JUST OVER THE TOP OF THAT THERE WERE FEW SMALL BLADDER STONES. SHE IS COMPLAINING OF RIGHT INGUINAL PAIN AND RIGHT LOWER ABD QUADRANT PAIN."

  Patient problems: Bowel Perforation; Erosion; Prolapse; Urinary Tract Infection

  MAUDE report 7173358 ↗
• InjuryNov 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING IN SUMMARY WAS REPORT VIA MAUDE EVENT REPORT (MW5072816): "I WAS IMPLANTED W/BARD SOFT MESH, A 100 PERCENT POLYPROPYLENE HERNIA MESH REPAIR. WITHIN 2 DAYS, PAIN WAS UNBEARABLE, DESPITE 3-4 PAIN KILLERS, INCL. A PAIN PUMP IV. THE PAIN WAS SLOW TO SUBSIDE OVER WEEKS, STARTED TO FEEL BETTER, THEN GOT WORSE AGAIN ALONGSIDE TENDERNESS OF INCISION SCAR. SIMULTANEOUSLY, AFTER HEALING BEGAN FROM THE OPEN SURGERY, I FOUND I WAS BECOMING IMPOTENT. EXTREME BURNING PAIN BEGINNING WITH ANY KIND OF SEXUAL OR SENSUAL STIMULATION AND THEN FEELING BLOCKED OR BACKED UP AND DEEP PAIN DURING EJACULATION. UPON REEXAMINATION BY THE SURGEON HE FOUND THERE WAS ABSOLUTELY NO NEW HERNIA. I AM CHILDLESS AND INFORMED POLYPROPYLENE DESTROYS THE VAS DEFERENS. IT SEEMS TO CAUSE LOTS OF PROBLEMS. I WONDERED ABOUT MY DEEP FATIGUE. THE BURNING, ITCHING SCAR AREA, ETC. BEFORE FINDING OUT. I'VE READ OF MANY OTHER COMPLICATIONS, SO I TAKE LOTS OF SUPPLEMENTS TO OFFSET THE FATIGUE AND OTHER SIDE EFFECTS TEMPORARILY, AT MY EXPENSE, WHILE PAID LITTLE. JUST SO I DON'T DIE RIGHT AWAY AND CAN KEEP WORKING. ONE SURGEON ADVISED THAT I NEED TO TAKE IT OUT, BUT SURGERY TO DO SO COSTS. LAWYERS MIGHT HELP IF FDA ISS

  Patient problems: Disability; Impotence; Pain

  MAUDE report 7049107 ↗