SEPRAMESH 5959812Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00801741031830), received between Sep 25, 2017 and Mar 2, 2026 — classified as 86 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (77 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 87 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL INCISIONAL HERNIA UPPER MIDLINE, VENTRAL INCISIONAL HERNIA LOWER MIDLINE, INCARCERATED VENTRAL INCISIONAL HERNIA RIGHT LOWER QUADRANT THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 1- UPPER MIDLINE, DEVICE 2 ¿ LOWER MIDLINE AND DEVICE 3 ¿ RIGHT LOWER QUADRANT). PER OPERATIVE NOTES, ¿THE INITIAL INCISION WAS MADE IN THE UPPER MIDLINE. THE HERNIA SAC WAS DISSECTED OUT. A SEPRAMESH IP (DEVICE 1) WAS PLACED INTO THE UPPER MIDLINE OF SUPRAUMBILICAL REGION AND SECURE IT WITH SUTURES. AN INCISION WAS MADE INTO THE LOWER MIDLINE. THE HERNIA SAC WAS DISSECTED OUT. A SEPRAMESH IP (DEVICE 2) WAS REINFORCED WITH (DEVICE 1) AND TACKED WITH TACKERS. THEN ATTENTION WAS TAKEN INTO THE LOWER RIGHT QUADRANT. THE HERNIA SAC WAS DISSECTED OUT. A SEPRAMESH IP (DEVICE 3) WAS PLACED INTO RIGHT LOWER QUADRANT AND SECURE IT WITH SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL INCARCERATED HERNIA (UPPER MIDLINE), SCAR TISSUE, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 4). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE UPPER SUPRAPUBIC

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24480854 ↗
• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE 1). PER OP NOTES, ¿A SMALL DEFECT WAS NOTED AT THE SUPERIOR ASPECT OF PREVIOUS CHEVRON INCISION. THE HERNIA WAS REDUCED AND ANOTHER TWO DEFECTS WERE NOTED AT INFERIOR ASPECT. A VENTRIO MESH (DEVICE 1) WAS PLACED TO COVER THE ENTIRE LENGTH OF INCISION BY INCORPORATING ALL THE DEFECTS USING SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF SEPRAMESH IP (DEVICE 2). PER OP NOTES, ¿PATIENT HAD DENSE ADHESIONS BETWEEN THE BOWEL, THE OMENTUM, ABDOMINAL WALL, AND PRIOR MESH WERE LYSED. THE MESH (DEVICE 1) NOT INCORPORATED TO ABDOMINAL WALL WAS DEBRIDED AWAY. THE INCISIONAL HERNIA WAS NOTED ALONG THE COSTAL MARGIN WITH INNUMERABLE SMALL AND MEDIUM SIZED DEFECTS. A SEPRAMESH IP (DEVICE 2) WAS PLACED TO THE DEFECT AND SECURED USING TACKS.¿ (B)(6) 2021 ¿ PATIENT WAS DIAGNOSED WITH MESH INFECTION AND CHRONIC DRAINING SINUS THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND PARTIAL REMOVAL OF MES

  Patient problems: Adhesion(s); Purulent Discharge; Unspecified Infection

  MAUDE report 24320789 ↗
• InjuryDec 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO SEPRAMESH IP MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿IN THE RIGHT LOWER QUADRANT MIDLINE, A LARGE INCISIONAL HERNIA DEFECT IN RIGHT LOWER QUADRANT AND PERIUMBILICAL AREA WAS NOTED. BOTH DEFECTS WERE COMBINED TOGETHER AND TWO SEPRAMESH IP (DEVICE 1 AND 2) WAS PLACED. THE ADHESIONS OF OMENTUM FROM ANTERIOR ABDOMINAL WALL WAS LYSED AND FASCIA WAS CLOSED WITH SUTURES AND TACKS CIRCUMFERENTIALLY.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL VENTRAL HERNIA WITH ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿THE RECURRENT HERNIA IN THE DEEP FASCIA OF RIGHT LOWER QUADRANT WAS NOTED. THE SAC AND PART OF MESHES (DEVICE 1 AND 2) WERE EXCISED. ADHESIONS WERE SHARPLY TAKEN DOWN AND FASCIA WAS CLOSED AND SUTURED AND STAPLED TO PREVIOUS MESHES (DEVICE 1 AND 2). (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE HERNIA S

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23848479 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OPERATIVE NOTES, IN THE MIDLINE, HERNIA SAC WAS EXCISED AND ADHESIONS WERE REDUCED. THE LARGE COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED WITH SUTURES AND TACKS.¿ (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL INCISIONAL HERNIA AND PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE SIGNIFICANT AMOUNT OF ADHESIONS INVOLVING MESH (DEVICE 1) AND SMALL BOWEL WERE LYSED. THE HERNIA CONTENTS WERE REDUCED AND SEPRAMESH IP (DEVICE 2) WAS PLACED OVER THE HERNIA DEFECT AND SUTURED.¿ (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH LEFT FLANK INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH REMOVAL OF COMPOSIX KUGEL MESH (DEVICE 1) AND IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE OLD MESH (DEVICE 1) WAS SEEN CONTRACTED AND WADDED UP SUPERFASCIAL TO PREVIOUS MESH (DEVICE 2). THE MESH (DEVICE 1) WAS REMOVED. THE OVERLYING SKIN IN THIS AREA WAS THINNED AND ISCHEMIC. ADHESIONS OF ANTERIOR ABDO

  Patient problems: Adhesion(s); Hernia; Ischemia

  MAUDE report 23616605 ↗
• InjuryOct 30, 2025Migration; Migration

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OP NOTES, ¿THE VENTRAL HERNIA DEFECT COVERED THE ENTIRE AREA FROM THE UMBILICUS TO THE SUPRAPUBIC REGION. A COMPOSIX E/X MESH (DEVICE 1) WAS LAID WITH SMOOTH SURFACE TOWARDS THE INTESTINE AND ROUGHER SURFACE ANTERIORLY USING SUTURES." (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF SEPRAMESH IP (DEVICE 2). PER OP NOTES, ¿INFRAUMBILICAL SCAR WAS DISSECTED. MOST OF THE MESH (DEVICE 1) WAS INTACT EXCEPT FOR THE INFERIOR PART WHICH HAD PULLED OFF. THE PREVIOUS MESH (DEVICE 1) WAS REMOVED. ADHESIONS WERE RELEASED. A SEPRAMESH IP (DEVICE 2) WAS PLACED IN THE SPACE BETWEEN THE BLADDER AND SUPRAPUBIC REGION USING SUTURES.¿ (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 2) AND IMPLANT OF SEPRAMESH IP (DEVICE 3). PER OP NOTES, ¿THE PREVIOUS MESH (DEVICE 2) HAD PULLED APART IN MOST OF ITS EDGES AND TORN APART

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

  MAUDE report 23422471 ↗
• InjuryJun 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT LARGE TWO VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO SEPRAMESH IP (DEVICE #1 AND DEVICE #2). PER OPERATIVE NOTES, ¿TWO SEPRAMESH IP (DEVICE #1 AND DEVICE #2) WAS PLACED ON LEFT AND RIGHT SIDE AND SUTURED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, EROSION OF LEFT SIDE SEPRAMESH IP (DEVICE #2) INTO THE SMALL BOWEL, DENSE EXTENSIVE ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF THE SEPRAMESH IP (DEVICE #2). PER OPERATIVE NOTES, ¿SEPRAMESH IP (DEVICE #2) WAS REMOVED.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE #1) AND IMPLANT OF TWO VENTRALIGHT ST MESH (DEVICE #3 AND DEVICE #4). PER OPERATIVE NOTES, ¿SEPRAMESH IP (DEVICE #1) WAS REMOVED. TWO VENTRALIGHT ST MESH (DEVICE #3 AND DEVICE #4) WAS PLACED AND SUTURED.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22176181 ↗
• InjuryMar 6, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS AND ABSCESS, ABDOMINAL WOUND THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO BARD FLAT MESH (DEVICE #3, DEVICE #4) ON (B)(6) 2006. PER OPERATIVE NOTES, ¿THE RIGHT INGUINAL HERNIA WAS FOUND. THE FLOOR OF THE DIRECT INGUINAL HERNIA WAS REPAIRED USING A PIECE OF BARD FLAT MESH (DEVICE #3), WHICH WAS PLACED WITH SUTURES. ON LEFT SIDE, THERE WAS A LARGE CORD LIPOMA AND ATTENUATED FLOOR CONSISTENT WITH DIRECT INGUINAL HERNIA. THE FLOOR WAS REPAIRED WITH BARD FLAT MESH (DEVICE #4), WHICH WAS PLACED IN A SIMILAR FASHION AS ON THE RIGHT WITH SUTURES. THE LARGE, CONTRACTED WOUND WAS NOTED, AND SCAR WAS EXCISED. THE PURULENT FLUIDS WERE DRAINED.¿ (B)(6) 2006 - PATIENT HAD WOUND DEHISCENCE, NEURALGIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿ON LEFT GROIN, CLOUDY SEROSANGUINEOUS FLUID WAS IDENTIFIED IN THE WOUND WERE RINSED. THE BARD FLAT MESH (DEVICE #4) WAS FREED FROM THE SURROUNDING TISSUE. DUE TO EXTENSIVE SCARRING, THE SPERMATIC CORD WAS DIFFICULT TO IDENTIFY AND LYSIS OF THE GENITAL FEMORAL NERVE WAS PERFORMED.¿ (B)(6) 2006 - PATIENT HAD LEFT HYDROCELE THEREBY UNDERWENT HYDROCEL

  Patient problems: Hernia; Obstruction/Occlusion; Scar Tissue

  MAUDE report 21536168 ↗
• InjuryAug 26, 2024Defective 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 SEPRAMESH COMPOSITE IP ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH COMPOSITE IP. ATTORNEY ALLEGES THAT THE PATIENT HAD INJURY ON (B)(6) 2015. 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); Bowel Perforation; Drug Resistant Bacterial Infection; Hematoma; Insufficient Information; Ischemia; Obstruction/Occlusion; Pain

  MAUDE report 20061967 ↗
• InjuryNov 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR AND WAS IMPLANTED WITH A SEPRAMESH IP ON (B)(6) 2023. THE PATIENT DID WELL AND WAS DISCHARGED EIGHTEEN (18) HOURS AFTER THE PROCEDURE. AS REPORTED A FEW HOURS AFTER DISCHARGE, THE PATIENT RETURNED IN SEPTIC SHOCK AND WAS DIAGNOSED WITH PTE (PULMONARY THROMBOEMBOLISM) AND DEVELOPED SEPSIS. THE SURGEON EMPHASIZED THAT HE IS NOT ATTRIBUTING THE COMPLICATION TO THE MESH, BUT THAT HE IS RAISING ALL POSSIBILITIES BECAUSE THEY HAVE NOT IDENTIFIED THE POSSIBLE CAUSE OF THE COMPLICATION.

  Patient problems: Sepsis; Septic Shock; Thromboembolism

  MAUDE report 18049613 ↗
• InjuryJul 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/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH COMPOSITE IP. 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); Insufficient Information; Pain

  MAUDE report 17422703 ↗
• InjuryJul 5, 2023Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED BY ATTORNEY: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH LARGE INCARCERATED VENTRAL HERNIAS AND UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO SEPRAMESH IP MESHES (DEVICE#1, DEVICE#2). PER OPERATIVE NOTES, " SEVERAL SMALL DEFECTS AND A LARGE DEFECT WAS ENCOUNTERED. A PIECE OF (SEPRAMESH ¿ DEVICE #2) MESH WAS SEWN TO ANOTHER PIECE OF (SEPRAMESH ¿ DEVICE #1) MESH USING SUTURES. THE MESH WAS TACKED USING MULTIPLE SPIRAL TACKS.". (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCISIONAL SITE WOUND DEHISCENCE. (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH LARGE VENTRAL HERNIA WITH CHRONIC ABDOMINAL WOUND AND UNDERWENT INCISION AND DEBRIDEMENT OF ABDOMINAL WALL WITH PLACEMENT OF VACUUM ASSISTED CLOSURE. PER OPERATIVE NOTE, ¿THERE WAS NO MESH EXPOSED¿. (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA WITH INFECTED ABDOMINAL WALL MESH AND UNDERWENT OPEN REPAIR FOR THE REMOVAL OF INFECTED MESH. PER OPERATIVE NOTES, "THE MESH WAS SEPARATED FROM THE UNDERLYING BOWEL, AND ENTEROCUTANEOUS FISTULA, WHICH WAS ADHERENT TO THE OVERLYING MESH, WHICH APPEARED TO HAVE ERODED INTO THE BOWEL. THE SPILLAGE OF BOWEL CONTENTS WERE CONTROLLED BY CLAMPS. THE MESH WAS SEPARATED AND A

  Patient problems: Adhesion(s); Bowel Perforation; Drug Resistant Bacterial Infection; Erosion; Fistula

  MAUDE report 17255340 ↗
• InjuryMay 18, 2023Defective 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/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2005. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST SEPRAMESH COMPOSITE IP. 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; Obstruction/Occlusion; Pain

  MAUDE report 16951219 ↗
• InjuryFeb 2, 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 SEPRAMESH IP ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH IP. 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: Abscess; Adhesion(s); Hernia; Insufficient Information; Unspecified Infection

  MAUDE report 13420910 ↗
• InjuryJan 26, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL SEPRAMESH IP (CAT #5959812 AND LOT #HUWI1169). IT IS ALLEGED THAT ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH THE PRODUCT IN THE COURSE OF A VENTRAL HERNIA REPAIR SURGERY. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF HERNIA RECURRENCE, SCAR TISSUE, INFECTION, FISTULA, BOWEL OBSTRUCTION AND CHRONIC PAIN. IT IS ALLEGED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A CORRECTIVE REVISION SURGERY. THE PATIENT UNDERWENT ANOTHER CORRECTIVE REVISION SURGERY ON (B)(6) 2018. ATTORNEY ALLEGES 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 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 ALL

  Patient problems: Fistula; Hernia; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 13358101 ↗
• InjurySep 12, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2014, THE PATIENT UNDERWENT SURGERY FOR AN INCISIONAL HERNIA REPAIR AND A BARD/DAVOL SEPRAMESH IP WAS IMPLANTED. ATTORNEY ALLEGES THAT FURTHER TO IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF MESH INFECTION, GASTROINTESTINAL COMPLICATIONS, BLADDER COMPLICATIONS AND CHRONIC PAIN. IT IS ALSO ALLEGED THAT THE PATIENT UNDERWENT ANOTHER CORRECTIVE REVISION SURGERY ON OR ABOUT (B)(6) 2019. 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 THE PATIENT SUFFERED PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT, SUFFERING AND PHYSICAL DISABILITY. IT IS ALLEGED THAT THE PATIENT CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Pain; Unspecified Gastrointestinal Problem; Unspecified Infection

  MAUDE report 12457830 ↗
• InjuryAug 14, 2021Detachment of Device or Device Component; Patient Device Interaction Problem; Migration; Detachment of Device or Device Component; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL SEPRAMESH IP ON (B)(6) 2009 FOR A HERNIA REPAIR. IT IS ALLEGED THAT FURTHER TO IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF ABDOMINAL PAIN, A LARGE HYPOECHOIC MASS PROJECT INFERIOR TO THE UMBILICUS, RECURRENT VENTRAL HERNIAS, MESH BULGES, DETACHMENT AND DISPLACEMENT OF THE LEFT LATERAL ASPECT OF THE PRODUCT, NECESSITATING REMOVAL OF THE PRODUCT. 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 FORMS OF MEDICAL CARE. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Hernia; Nodule

  MAUDE report 12322181 ↗
• InjuryMay 24, 2021Defective 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/DAVOL SEPRAMESH IP ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST SEPRAMESH IP. 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; Adhesion(s); Fistula; Insufficient Information; Purulent Discharge; Unspecified Infection

  MAUDE report 11873415 ↗
• InjuryApr 29, 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/DAVOL SEPRAMESH IP ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH IP. 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; Scar Tissue

  MAUDE report 11744727 ↗
• InjuryFeb 4, 2021Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH, SEPRAMESH COMPOSITE IP AND VENTRALEX ST ON (B)(6) 2007 AND/OR (B)(6) 2010 AND/OR (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL 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); Disability; Hernia; Injury; Obstruction/Occlusion; Pain

  MAUDE report 11279745 ↗
• InjuryJan 19, 2021Defective 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 UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH ON (B)(6) 2009 AND SEPRAMESH IP ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE 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: Adhesion(s); Hernia; Injury

  MAUDE report 11191898 ↗
• InjuryOct 28, 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 THE IMPLANT OF UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP (X2) ON (B)(6) 2009 AND (B)(6) 2010. 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: Disability; Injury; Pain

  MAUDE report 10747502 ↗
• InjuryOct 26, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP (X2) ON (B)(6) 2009 AND (B)(6) 2010. 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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 10732433 ↗
• InjuryAug 18, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH TWO NON-BARD/DAVOL MESH PRODUCTS TO REPAIR A HERNIA. THE NON-BARD/DAVOL MESH FAILED, CAUSING THE PATIENT TO EXPERIENCE SEVERE PAIN AND SUFFERING, AND NECESSITATING A PARTIAL MESH REMOVAL AND REVISION SURGERY ON (B)(6) 2018. A BARD/DAVOL PRODUCT NAMELY SEPRAMESH IP WAS USED IN THE REPAIR. THE DEFECTIVE MESH DEVICES HAS CAUSED THE PATIENT TO EXPERIENCE SEVERE PAIN AND SUFFERING AND LEFT THE PATIENT LIVING WITH CHRONIC PAIN. THE PATIENT SUFFERED SEVERE COMPLICATIONS FOLLOWING SURGERIES INCLUDING ABDOMINAL PAIN, GASTROINTESTINAL MALFUNCTION, GROTESQUE SWELLING AND HERNIA RECURRENCE. DUE TO THE IMPLANTATIONS AND FAILURES OF THE DEFECTIVE MESH DEVICES, THE PATIENT EXPERIENCED PERMANENT INJURIES AND IMPAIRMENTS, INCLUDING SCARRING, DISFIGUREMENT, CHRONIC PAIN, AND OTHER FURTHER INJURIES. THE INJURIES DUE TO IMPLANTATION OF DEFECTIVE MESH DEVICES HAS CAUSED AND CONTINUE TO CAUSE THE PATIENT PAIN, SUFFERING, PERMANENT PHYSICAL DISABILITY AND LOSS OF PHYSICAL, MENTAL AND EMOTIONAL HEALTH. THE PATIENT CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT AND ALLEGES FOR FURTHER MEDICAL CARE IN FORESEEABLE FUTURE. IT IS ALSO ALLEGE

  Patient problems: Deformity/ Disfigurement; Disability; Hernia

  MAUDE report 10421258 ↗
• InjuryJun 23, 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 UNSPECIFIED BARD/ DAVOL SEPRAMESH IP AND VENTRALEX HERNIA PATCH ON (B)(6) 2014 AND/OR (B)(6) 2015 AND/OR (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE 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; Injury

  MAUDE report 10183503 ↗
• InjuryJun 16, 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 THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH COMPOSITE IP. 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); Disability; Hernia; Injury; Ischemia; Necrosis; Pain; Strangulation

  MAUDE report 10157276 ↗