BARD 0117010Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741030871), received between Jun 6, 2017 and Sep 18, 2026 — classified as 16 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Unsealed Device Packaging

  As reported, during a laparoscopic inguinal hernia surgery, the surgeon opened the Bard Soft Mesh package and discovered that the inner pouch was not sealed. To ensure patient safety, a new mesh was used. The outer packaging was intact with no visible damage, the product box was completely sealed, and the package had not been opened prior to entering the operating room. There was no patient injury/harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816794 ↗
• InjuryAug 17, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2018- Patient was diagnosed with symptomatic left inguinal hernia thereby underwent laparoscopic repair with implant of Bard Soft Mesh (Device 1) and a synthetic mesh. Per op notes, "An incision was made to the subcutaneous tissue and extended until the anterior rectus sheath was encountered. A large indirect inguinal hernia was identified. On the right-side, a small to moderate sized inguinal hernia was identified and reduced. There was no direct hernia identified. A synthetic mesh was placed, aligned from the ASIS to mid of the pubis and secured with tacks to the Cooper¿s ligament. On the left side, a Bard Soft Mesh (Device 1) was placed and aligned from the ASIS to mid of the pubis and secured with tacks. Both the meshes were positioned posterior and lateral to the peritoneum and the fascia of the anterior rectus was closed with sutures."(b)(6) 2023- Patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with implant of Bard Soft Mesh (Device 2). Per op notes, "A left inguinal incision was made. The fascia was opened to the external ring. Scarring from the previous procedure and previous inguinal scar was identifie

  Patient problems: Hernia; Nerve Damage; Scar Tissue

  MAUDE report 50273984 ↗
• InjuryFeb 14, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1), BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿THE HERNIA DEFECT IN THE ABDOMINAL REGION WAS DISSECTED. A VENTRIO MESH (DEVICE 1) WAS PLACED PREPERITONEAL AND SUTURED. A BARD SOFT MESH (DEVICE 2) WAS PLACED AS AN ONLAY TO THE FASCIA AND SUTURED¿. (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRIO MESH (DEVICE 1), BARD SOFT MESH (DEVICE 2) AND IMPLANT OF ALLOMAX SURGICAL GRAFT (DEVICE 3), BARD FLAT MESH (DEVICE 4). PER OP NOTES, ¿THE PREVIOUSLY MADE SCAR WAS REMOVED. THE SAC IN THE ABDOMINAL REGION ALONG WITH THE PREVIOUSLY PLACED MESH WAS REMOVED. AN ALLOMAX SURGICAL GRAFT (DEVICE 3) WAS PLACED INTRA ABDOMINALLY AND SUTURED. A BARD FLAT MESH (DEVICE 4) WAS PLACED AS AN ONLAY AND SUTURED¿. (B)(6) 2013- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 5) AND BARD FLAT MESH (DEVICE 6). PER OP NOTES, ¿IN MIDLINE INCISION, AN OPENING IN THE FASCIA WAS IDENTIFIED AND A PERFIX PLUG (DEVICE 5) WAS PLACED AND

  Patient problems: Hernia; Scar Tissue

  MAUDE report 24340555 ↗
• InjurySep 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH PERISTOMAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 1) AND BARD SOFT MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS REMOVED. A VENTRALEX ST MESH (DEVICE 1) AND BARD SOFT MESH (DEVICE 2) WAS PLACED INTO THE RIGHT ABDOMEN AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT PERISTOMAL HERNIA, BOWEL OBSTRUCTION, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 3) AND VENTRALIGHT ST MESH (DEVICE 4). PER OPERATIVE NOTES, ¿RIGHT SIDE OF THE ABDOMEN THERE WAS A PARASTOMAL HERNIA SAC. HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED VENTRALEX ST MESH (DEVICE 1) AND BARD SOFT MESH (DEVICE 2) WAS INTACT. A VENTRALEX ST MESH (DEVICE 3) AND VENTRALIGHT ST MESH (DEVICE 4) WAS PLACED INTO THE RIGHT ABDOMEN TOGETHER AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WOUND, VENTRAL HERNIA BOWEL OBSTRUCTION THEREBY UNDERWENT REPAIR WITH ABDOMINAL WASHOUT AND WOUND VAC PLACEMENT AND IMPLANT OF BARD SOFT MESH (DEVICE 5). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. A BARD SOFT MESH

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

  MAUDE report 23026153 ↗
• InjuryJul 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH. PER OPERATIVE NOTES, ¿LARGE SCARRED HERNIA SAC WAS IDENTIFIED, DISSECTED CIRCUMFERENTIALLY AND REMOVED. A COMPOSIX KUGEL MESH WAS PLACED FOR THE REPAIR AND SECURED WITH SUTURES.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT SYMPTOMATIC INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH BARD SOFT MESH (DEVICE # 2). PER OPERATIVE NOTES, ¿THE LOOPS OF SMALL BOWEL ADHERENT TO THE MESH (DEVICE #1) WERE REMOVED. THE OLD MESH (DEVICE # 1) APPEARED TO BE INTACT. THE SAC WAS DISSECTED CIRCUMFERENTIALLY AND RESECTED. THE FASCIAL DEFECT CLOSED WITH SUTURES AND BARD SOFT MESH (DEVICE #2) WAS PLACED AND SECURED CIRCUMFERENTIALLY WITH SUTURES.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND SMALL BOWEL OBSTRUCTION AND ADHESION THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PREVIOUSLY PLACED MESH (DEVICE # 1 AND # 2) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿THE SMALL BOWEL WAS SEEN ADHERED TO THE MESH. THE INTERLOOP ADHESIONS AND KUGEL MESH (DEVICE # 1) WAS R

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

  MAUDE report 22410413 ↗
• InjuryJul 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT LAPAROSCOPIC HERNIA REPAIR ON (B)(6) 2020 AND WAS IMPLANTED WITH A SOFT MESH WITH POSTOPERATIVE HAEMOSTASIS, PAIN RELIEF, AND SYMPTOMATIC MANAGEMENT. AS REPORTED, THERE WAS SUPPURATION OF THE INCISION AND THE PATIENT UNDERWENT PUNCTURE TO EXTRACT FLUID AND THE INCISION WAS TREATED WITH ANTI-INFECTIVE THERAPY. REPORTEDLY, THE INCISION HEALED ON (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 22374208 ↗
• MalfunctionMay 8, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, THE NURSE FOUND THAT THERE WAS A CRACK ON THE OUTER PACKAGE BAG OF BARD SOFT MESH. IT WAS REPORTED THAT THE BOX WAS COMPLETELY SEALED. IT WAS ALSO REPORTED THAT THE MESH WAS NOT USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986525 ↗
• InjuryOct 16, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE: "COMPARISON OF OPEN PREPERITONEAL AND TRANSABDOMINAL PREPERITONEAL HERNIA REPAIR FOR PRIMARY UNILATERAL FEMORAL HERNIA" THIS ARTICLE IS A RETROSPECTIVE STUDY OF COMPARISON OF THE OUTCOMES OF OPEN AND LAPAROSCOPIC SURGICAL FEMORAL HERNIA (FH) TREATMENT. A TOTAL OF 132 PATIENTS WITH PRIMARY UNILATERAL FEMORAL HERNIA (FH) WERE RECRUITED FOR THIS STUDY IN WHICH 62 PATIENTS UNDERWENT OPEN SURGERY (OS) AND 70 PATIENTS UNDERWENT TRANSABDOMINAL PREPERITONEAL (TAPP) PROCEDURE IN BEIJING CHAO-YANG HOSPITAL FROM JANUARY 2013 TO JUNE 2018. AS REPORTED, 10 CM X 10 CM NON-BD MESH (62 PATIENTS) WAS IMPLANTED IN OS GROUP, WHEREAS 10 CM × 15 CM BARD SOFT MESH (43 PATIENTS) AND NON-BD MESH (27 PATIENTS) WERE IMPLANTED AND FIXATED WITH MEDICAL GLUE IN TAPP GROUP. FOLLOW-UP REVIEW WAS CONDUCTED AT 1, 3, 6 AND 12 MONTHS POSTOPERATIVELY. POST IMPLANT OF BARD SOFT MESH IN THE TAPP GROUP HAD COMPLICATIONS OF VESSEL INJURY (1), SEROMA (5) AND URINARY RETENTION (1). SEROMA IS THE MOST FREQUENT OBSERVED COMPLICATION IN PATIENTS WHO UNDERWENT TAPP REPAIR AND ALL SEROMAS RESOLVED WELL WITH CONSERVATIVE TREATMENT WITHIN 2 MONTHS. THE OVERALL COMPLICATION RATES WERE EQUIVALENT BETWEEN THE OS

  Patient problems: Seroma; Urinary Retention

  MAUDE report 20464609 ↗
• InjurySep 2, 2024Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER MEDICAL RECORDS: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCARCERATED ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD SOFT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A DEFECT WAS IDENTIFIED. THE BOWEL THAT WAS ADHERENT TO IT WAS FREED SHARPLY AND THERE WAS NO EVIDENCE OF ANY ISCHEMIC BOWEL. AN ONLAY BARD SOFT MESH (DEVICE #1) WAS SUTURED IN PLACE.¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA, PAIN AND POSSIBLE PARTIAL SMALL-BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO VENTRALIGHT ST MESHES (DEVICE #2 & #3). PER OPERATIVE NOTES, ¿THERE WAS A COMBINATION OF HERNIA SAC AND MESH. SCAR TISSUE WAS INCISED OFF THE MESH AND ALL THE ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WERE THEN REMOVED. THERE WAS A LARGE DEFECT IN WHICH THE MESH (DEVICE #1) WAS QUITE SUPERFICIAL THAT COULD NOT BE REMOVED. A VENTRALEX ST MESH (DEVICE #2 & #3) WAS PLACED AS IT REQUIRED TWO PIECES BECAUSE OF THE WOUND SIZE.¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO VENTRIO ST MESHES (DEVICE #4 & #5). PER OPERATIVE NOTES, ¿THERE WAS A LARGE SEROMA BETWEEN THE ARE

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

  MAUDE report 20117998 ↗
• InjuryMay 7, 2024Defective 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 SOFT MESH ON (B)(6)2023. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BARD SOFT 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 19257128 ↗
• MalfunctionApr 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, BEFORE REMOVING THE PRODUCT FROM THE PACKAGING, IT WAS NOTED THAT THERE WAS A HAIR IN THE INNER PACKAGING. THE MESH WAS NOT USED TO PERFORM A PROCEDURE AND ANOTHER MESH WAS THEN USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088275 ↗
• MalfunctionDec 14, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, AFTER RECEIVING THE SOFT MESH FOR A PROCEDURE, THE OUTER PACKAGE WAS OPENED AND FOUND THAT THERE WERE UNKNOWN FILAMENTS (FOREIGN MATERIAL) WITHIN THE INNER PACKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325261 ↗
• InjuryOct 31, 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) 2021. 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: Hernia; Insufficient Information; Pain

  MAUDE report 18038948 ↗
• InjuryNov 17, 2022Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT ON (B)(6) 2010, THE PLAINTIFF WAS IMPLANTED WITH THE BARD SOFT MESH IN THE COURSE OF A LEFT INGUINAL HERNIA REPAIR SURGERY. ATTORNEY ALLEGES THAT FURTHER TO THE PLAINTIFF IMPLANTATION WITH THE PRODUCT, THE PLAINTIFF SUFFERED THE DEVELOPMENT OF HERNIA RECURRENCE, AND CHRONIC PAIN. ATTORNEY ALLEGES THAT ON (B)(6) 2010, (B)(6) 2017 AND (B)(6) 2018, THE PLAINTIFF UNDERWENT CORRECTIVE REVISION SURGERIES. IT IS ALLEGED THAT THE PLAINTIFF "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 PLAINTIFF WAS LEFT WITH PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT, AND CHRONIC PAIN. IT IS ALLEGED THAT THE PLAINTIFF CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Deformity/ Disfigurement; Hernia; Pain; Scar Tissue

  MAUDE report 15812848 ↗
• InjuryOct 4, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2015: THE PATIENT UNDERWENT A UMBILICAL HERNIA REPAIR PROCEDURE TO INTRODUCE A BARD/DAVOL SOFT MESH TO THE PATIENT'S PERITONEAL CAVITY TO REINFORCE TISSUE AFFECTED BY THE HERNIA . (B)(6) 2015: THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A SEVERE INFECTION OF THE MESH FROM HIS JUNE HERNIA MESH SURGERY IN WHICH THE BARD/DAVOL BARD SOFT MESH WAS USED. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT WHERE AN INCISION AND DRAINAGE PROCEDURE (I&D) WAS PERFORMED, FOLLOWED BY ADMINISTERING AN ANTI-BIOTIC TREATMENT THAT SPANNED THE COURSE OF THREE DAYS. THE INFECTION IS ALLEGED TO HAVE BEEN MRSA. THE PATIENT EXPERIENCED A LACK OF NATURAL BOWEL MOVEMENT CAUSING HIM TO HAVE TO INGEST LAXATIVES DAILY TO MAINTAIN REGULARITY. IT IS ALLEGED THAT THE BARD/DAVOL SOFT MESH IS DEFECTIVE. AS ALLEGED, THE PATIENT HAS SUFFERED SERIOUS BODILY INJURIES THAT HAVE RESULTED IN PAIN AND SUFFERING, DISABILITY, AND MENTAL ANGUISH.

  Patient problems: Disability; Pain; Unspecified Infection

  MAUDE report 7933841 ↗
• InjuryDec 13, 2017Defective Device; Defective Device

  THE FOLLOWING IS BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2009 - THE PATIENT WAS DIAGNOSED WITH PROLAPSE OF VAGINAL VAULT, MIXED INCONTINENCE URGE AND STRESS INCONTINENCE. THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY WITH IMPLANT OF A BARD SOFT MESH AND IMPLANT OF A NON-BARD DAVOL URETHRAL SLING FOLLOWED BY CYSTOSCOPY. ON (B)(6) 2011 - THE PATIENT WAS DIAGNOSED PELVIC PAIN AND UNDERWENT AN EXPLORATORY LAPAROTOMY WITH PARTIAL EXPLANT OF BARD SOFT MESH. PER OPERATIVE DETAILS, "ATTENTION WAS TURNED TO THE ABDOMINAL SACROCOLPOPEXY MESH WHICH WAS IDENTIFIED IN ITS PROPER LOCATION FROM THE SACRAL PROMINENCE TO THE VAGINAL CUFF/ CERVICAL STUMP." ON (B)(6) 2012 - THE PATIENT WAS DIAGNOSED WITH A VAGINAL ENTEROCELE AND CYSTOCELE. THE PATIENT UNDERWENT A VAGINAL ANTERIOR/POSTERIOR REPAIR WITH IMPLANT OF A NON-BARD DAVOL "TUTOPLAST FASCIA LATA."NO MENTION OF ANY INVOLVEMENT OR VISUALIZATION OF THE BARD SOFT MESH.

  Patient problems: Pain; Prolapse

  MAUDE report 7112788 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5072968): "I HAD AN INCISIONAL HERNIA MESH REPLACEMENT IN 2016. THE MESH USED WAS BARD SOFT MESH 10 X 15 CMS WHICH WAS CORRECTLY IMPLANTED BY MY SURGEON. I DEVELOPED A SEROMA AND A LOT OF BLOOD COLLECTED IN THE AREA OF THE MESH. SURGEONS AT THE HOSPITAL DRAINED OUT QUITE A FEW OUNCES OF BLOOD. IT CONTINUED ACCUMULATING AND THEY EVENTUALLY PUT IN A TUBE WITH DRAINAGE BAG. AFTER ABOUT 2 MONTHS, THE PROBLEM EASED AND FINALLY STOPPED. HOWEVER, THEN I DEVELOPED SERIOUS PAIN IN THE AREA WHERE THE MESH HAS BEEN IMPLANTED. THE SURGEONS ADVISED THAT THEY WILL HAVE TO REMOVE THE MESH AND REPLACE WITH A BIOLOGICAL MESH, HOWEVER, THEY ASKED ME TO SEEK PAIN MANAGEMENT WHICH I DID. I WAS PUT ON HYDROCODONE AND AM SCARED THAT I WILL BECOME ADDICTED. THE PAIN IS WORSENING BY THE WEEK AND I AM HAVING TO LIVE A VERY STRESSED AND UNCOMFORTABLE EXISTENCE." THERE IS SOMETHING SERIOUSLY WRONG WITH THIS MESH. I HAD MESH IMPLANTS PREVIOUSLY BUT NEVER HAD THIS KIND OF PROBLEM."

  Patient problems: Hematoma; Pain; Seroma

  MAUDE report 7072852 ↗
• InjurySep 26, 2017Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  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) 2012 - THE PATIENT WAS DIAGNOSED WITH VAGINAL VAULT PROLAPSE AND UNDERWENT AN ABDOMINAL SACROCOLPOPEXY WITH IMPLANT OF A BARD SOFT MESH. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED UNSPECIFIED ADVERSE PATIENT OUTCOME ASSOCIATED TO THE USE OF THE DEVICE.

  Patient problems: No Information

  MAUDE report 6895760 ↗
• InjurySep 25, 2017Shelf Life Exceeded; Use of Device Problem; Shelf Life Exceeded; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT WAS IMPLANTED WITH TWO BARD SOFT MESH DEVICES. AS REPORTED DURING THE COMPLETION OF THE PROCEDURE AND CLOSING THE PATIENT, THE NURSE REALIZED THAT ONE OF THE IMPLANTS WAS PAST THE EXPIRATION DATE OF 12/31/2016. IT WAS REPORTED THAT THE PATIENT HAD RECEIVED IV ANCEF PREOPERATIVELY AND AN IRRIGATION OF ANTIBIOTIC SOLUTION AFTER THE PROCEDURE WAS COMPLETED. ADDITIONALLY, THE PATIENT WAS KEPT IN THE HOSPITAL FOR AN OVERNIGHT STAY AND GIVEN 2 MORE DOSES OF IV ANTIBIOTICS BEFORE DISCHARGE. THERE WAS NO REPORTED PATIENT INJURY AND THE MESH REMAINS IMPLANTED AT THIS TIME. THIS MDR IS FILED AS A SERIOUS INJURY AS PRECAUTIONARY MEASURES WERE TAKEN BY THE USER FACILITY AND THE PATIENT WAS ADMINISTERED ADDITIONAL MEDICATION AND REMAINED IN THE HOSPITAL OVERNIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6892043 ↗
• InjurySep 15, 2017Defective 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 SOFT MESH AND A NON BARD DAVOL "DESARA" SLING. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED TO THE USE OF THE DEVICE.

  Patient problems: No Information

  MAUDE report 6870761 ↗
• MalfunctionSep 13, 2017Torn Material; Torn Material

  IT IS ALLEGED THAT DURING AN OPEN INGUINAL HERNIA REPAIR WHILE USING A BARD SOFT MESH, UPON REMOVING THE SOFT MESH FROM THE PACKAGING, IT WAS NOTED PRIOR TO USE, (BEFORE TAILORING THE MESH) THAT THE EDGES OF THE SOFT MESH WERE IRREGULARLY SHAPED. AS REPORTED, THE SURGEON PERFORMED THE "PANTALON TECHNIQUE" DURING AN OPEN INGUINAL HERNIA REPAIR AND WHILE SUTURING THE MESH, THE MESH TORE. THE SURGEON CONTINUED TO FIXATE THE MESH. HOWEVER, WITH "LONGER SUTURE POINTS" WITHOUT ANY ISSUE AND COMPLETED THE CASE. AS REPORTED THE MESH WAS IMPLANTED BECAUSE, ACCORDING TO THE SURGEON'S CRITERIA, THE MESH DID NOT PRESENT ANY DANGER OR RISK TO THE PATIENT. AS REPORTED, THERE HAS BEEN NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6861133 ↗
• MalfunctionSep 13, 2017Torn Material; Torn Material

  IT IS ALLEGED THAT DURING AN OPEN INGUINAL HERNIA REPAIR WHILE USING A BARD SOFT MESH, UPON REMOVING THE SOFT MESH FROM THE PACKAGING, IT WAS NOTED PRIOR TO USE, (BEFORE TAILORING THE MESH) THAT THE EDGES OF THE SOFT MESH WERE IRREGULARLY SHAPED. AS REPORTED, THE SURGEON PERFORMED THE "PANTALON TECHNIQUE" DURING AN OPEN INGUINAL HERNIA REPAIR AND WHILE SUTURING THE MESH, THE MESH TORE. THE SURGEON CONTINUED TO FIXATE THE MESH HOWEVER, WITH "LONGER SUTURE POINTS" WITHOUT ANY ISSUE AND COMPLETED THE CASE. AS REPORTED THE MESH WAS IMPLANTED BECAUSE, ACCORDING TO THE SURGEON'S CRITERIA, THE MESH DID NOT PRESENT ANY DANGER OR RISK TO THE PATIENT. AS REPORTED, THERE HAS BEEN NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6861131 ↗
• MalfunctionSep 13, 2017Torn Material; Torn Material

  IT IS ALLEGED THAT DURING AN OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2017 WHILE USING A BARD SOFT MESH, UPON REMOVING THE SOFT MESH FROM THE PACKAGING, IT WAS NOTED PRIOR TO USE, (BEFORE TAILORING THE MESH) THAT THE EDGES OF THE SOFT MESH WERE IRREGULARLY SHAPED. AS REPORTED, THE SURGEON PERFORMED THE "PANTALON TECHNIQUE" DURING AN OPEN INGUINAL HERNIA REPAIR AND WHILE SUTURING THE MESH, THE MESH TORE. THE SURGEON CONTINUED TO FIXATE THE MESH HOWEVER, WITH "LONGER SUTURE POINTS" WITHOUT ANY ISSUE AND COMPLETED THE CASE. AS REPORTED THE MESH WAS IMPLANTED BECAUSE, ACCORDING TO THE SURGEON'S CRITERIA, THE MESH DID NOT PRESENT ANY DANGER OR RISK TO THE PATIENT. AS REPORTED, THERE HAS BEEN NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6861130 ↗
• MalfunctionSep 13, 2017Torn Material; Torn Material

  IT IS ALLEGED THAT DURING AN OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2017 WHILE USING A BARD SOFT MESH, UPON REMOVING THE SOFT MESH FROM THE PACKAGING, IT WAS NOTED PRIOR TO USE, (BEFORE TAILORING THE MESH) THAT THE EDGES OF THE SOFT MESH WERE IRREGULARLY SHAPED. AS REPORTED, THE SURGEON PERFORMED THE "PANTALON TECHNIQUE" DURING AN OPEN INGUINAL HERNIA REPAIR AND WHILE SUTURING THE MESH, THE MESH TORE. THE SURGEON CONTINUED TO FIXATE THE MESH HOWEVER, WITH "LONGER SUTURE POINTS" WITHOUT ANY ISSUE AND COMPLETED THE CASE. AS REPORTED THE MESH WAS IMPLANTED BECAUSE, ACCORDING TO THE SURGEON'S CRITERIA, THE MESH DID NOT PRESENT ANY DANGER OR RISK TO THE PATIENT. AS REPORTED, THERE HAS BEEN NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6861129 ↗
• MalfunctionSep 13, 2017Torn Material; Torn Material

  IT IS ALLEGED THAT DURING AN OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2017 WHILE USING A BARD SOFT MESH, UPON REMOVING THE SOFT MESH FROM THE PACKAGING, IT WAS NOTED PRIOR TO USE, (BEFORE TAILORING THE MESH) THAT THE EDGES OF THE SOFT MESH WERE IRREGULARLY SHAPED. AS REPORTED, THE SURGEON PERFORMED THE "PANTALOON TECHNIQUE" DURING AN OPEN INGUINAL HERNIA REPAIR AND WHILE SUTURING THE MESH, THE MESH TORE. THE SURGEON CONTINUED TO FIXATE THE MESH HOWEVER, WITH "LONGER SUTURE POINTS" WITHOUT ANY ISSUE AND COMPLETED THE CASE. AS REPORTED THE MESH WAS IMPLANTED BECAUSE, ACCORDING TO THE SURGEON'S CRITERIA, THE MESH DID NOT PRESENT ANY DANGER OR RISK TO THE PATIENT. AS REPORTED, THERE HAS BEEN NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6861125 ↗