SEPRAMESH 5959360Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00801741031809), received between Jan 9, 2017 and Dec 19, 2025 — classified as 60 injuries.

The most frequently reported specific device problem is “Defective Device” (58 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿ALL THE ADHESIONS WERE TAKEN DOWN. THE HERNIA DEFECT WAS ENTERED AND REDUCED. A SEPRAMESH IP (DEVICE 1) WAS PLACED AND TACKED USING SORBAFIX TACKER.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH ADHESIONS THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE PRIOR MESH (DEVICE 1) WAS ENCOUNTERED AND OPENED. LARGE AMOUNT OF OLD SCAR WAS NOTED BEHIND THE PRIOR MESH AND EXCISED THE SCAR. ADHESIONS OF OMENTUM, COLON AND SMALL BOWEL WERE LYSED. ALL THE ADHESIONS WERE LYSED. RESECTION OF GASTROINTESTINAL ANASTOMOSIS FROM PREVIOUS VAGOTOMY AND PARTIAL GASTROTOMY WAS PERFORMED.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH ADHESIONS AND ABDOMINAL PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OP NOTES, ¿ADHESIONS ANTERIOR ABDOMINAL WALL WAS LYSED. A LARGE PRIOR MESH (DEVICE 1) NOTED IN UPPER ABDOMEN WAS INTACT. DENSE ADHESIONS LYSED. INTERNAL HERNIA DEFECT WAS NOTED AND REPAIRED WITH SUTURES.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH TWO VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH

  Patient problems: Abdominal Pain; Adhesion(s); Hernia

  MAUDE report 23848265 ↗
• InjuryJul 30, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED SPIGELIAN /ABDOMINAL WALL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED WITH INCARCERATED BOWEL. ALL THE BOWEL WAS REDUCED. A SEPRAMESH IP (DEVICE #1) WAS PLACED AND TACKED.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT SPIGELIAN/LATERAL ABDOMINAL WALL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #2 & #3) AND SEPRAMESH IP (DEVICE #4). PER OP NOTES, ¿A LARGE HERNIA SAC IN THE RIGHT UPPER QUADRANT WAS IDENTIFIED WITH INCARCERATED BOWEL. THE BOWEL WAS REDUCED. THE SAC WAS EXCISED. TWO PERFIX PLUGS (DEVICE #2 & #3) WERE PLACED NEXT TO EACH OTHER AND TACKED. A SEPRAMESH IP (DEVICE #4) WAS PLACED AS AN OVERLAY MESH AND TACKED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED RIGHT LOWER QUADRANT SPIGELIAN HERNIA WITH ABSCESS THEREBY UNDERWENT REPAIR WITH DRAINAGE OF ABSCESS. PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND NOT REDUCIBLE CONTAINS BOWEL. THE BOWEL WAS REDUCED HARDLY. THE SAC WAS EXCISED. THE PRIOR MESHES (DEVICE #1, #2, #3 & #4) WERE IDENTIFIE

  Patient problems: Fistula; Hernia; Unspecified Infection

  MAUDE report 22663356 ↗
• InjuryMay 5, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A COMPOSIX MESH (DEVICE #1) WAS PLACED AND SECURED BY SUTURES.¿ (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA AND SEROMA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿SEROMA WAS NOTED TO BE DRAINED INTO THE ABDOMEN. A COMPOSIX MESH (DEVICE #1) WAS COMPLETELY REMOVED FROM THE LOWER ABDOMINAL WALL. THEN A SYNTHETIC MESH WAS USED AND SECURED BY SUTURES. ¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿SCAR TISSUE AND HEMATOMA WAS NOTED, AND ADHESIONS WERE TAKEN DOWN. LARGE RECURRENT INCISIONAL HERNIA WAS NOTED. PREVIOUSLY PLACED MESH WAS IDENTIFIED OVER THE LOWER ABDOMEN. THEN ANOTHER SYNTHETIC MESH WAS INSERTED BEHIND THE MUSCLE USING SUTURES. ¿ (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIONS IN

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

  MAUDE report 21961836 ↗
• InjuryMay 10, 2024Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL MARLEX MESH (BARD FLAT MESH), SEPRAMESH COMPOSITE IP AND BARD SOFT MESH ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH COMPOSITE IP. IT IS ALLEGED THAT THE PATIENT HAD REVISION SURGERY ON OR ABOUT (B)(6) 2018 WITH REMOVAL OF HERNIA MESH AND IMPLANT OF ADDITIONAL HERNIA MESH. IT ALSO ALLEGED THAT THE PATIENT UNDERWENT REVISION SURGERY ON OR ABOUT (B)(6) 2022 FOR ADDITIONAL HERNIA 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. NOTE: IT IS ALLEGED THAT THE PATIENT UNDERWENT EXPLANT OF HERNIA MESH AND REVISION SURGERY FOR ANOTHER MESH (DEVICE #1 #2).

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 19288043 ↗
• 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 AB

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

  MAUDE report 17256960 ↗
• InjurySep 7, 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 COMPOSITE IP ON (B)(6) 2017. 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); Hernia; Insufficient Information; Pain

  MAUDE report 15367878 ↗
• InjuryAug 25, 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) 2011. 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: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 15293108 ↗
• InjuryMay 21, 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 UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2010 AND XENMATRIX ON (B)(6) 2011. 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; Pain; Unspecified Infection

  MAUDE report 14466800 ↗
• InjuryMar 8, 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 UNSPECIFIED BARD/DAVOL SEPRAMESH IP, VENTRALIGHT ST AND VENTRIO ST ON (B)(6) 2014 AND/OR (B)(6) 2015 AND/OR (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH IP AND VENTRALIGHT ST. 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

  MAUDE report 13693268 ↗
• InjuryNov 7, 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 COMPOSITE IP ON (B)(6) 2013. 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: Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 12763923 ↗
• InjuryAug 14, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL SEPRAMESH IP DURING A VENTRAL HERNIA REPAIR SURGERY. IT IS ALLEGED THAT FURTHER TO IMPLANTATION OF THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF PERSISTENT CHRONIC PAIN, SWELLING, FIBROTIC SCARRING, ADHESION INJURIES, BOWEL OBSTRUCTION AND HERNIA RECURRENCE. 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: Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 12322188 ↗
• InjuryAug 13, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2014, THE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR SURGERY AND A BARD/DAVOL SEPRAMESH IP WAS IMPLANTED. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION AND HERNIA RECURRENCE. 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: Hernia; Obstruction/Occlusion; Pain

  MAUDE report 12321436 ↗
• InjuryJul 1, 2021Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2010, VENTRALEX ST AND VENTRIO ST ON (B)(6) 2014, PHASIX MESH AND XENMATRIX AB ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2016. 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) 2010 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, ¿THE LIPOMA OF THE CORD WAS EXCISED. A SEPRAMESH IP (DEVICE #1) WAS PLACED AND SECURED TO THE FASCIA USING SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT COMPLEX VENTRAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE #1) AND IMPLANT

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 12097827 ↗
• InjuryApr 12, 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/DAVOL SEPRAMESH IP ON (B)(6) 2013 AND TWO VENTRALEX HERNIA PATCHES ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED 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

  MAUDE report 11647845 ↗
• InjuryNov 2, 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 MESH (BARD FLAT MESH) ON (B)(6) 2013, A BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2016 AND BRAD SOFT MESH ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH) AND SEPRAMESH COMPOSITE IP. IT IS ALLEGED THAT THE PATIENT UNDERWENT REVISION SURGERIES ON (B)(6) 2016 AND (B)(6) 2020. 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; Scar Tissue

  MAUDE report 10770659 ↗
• InjuryOct 22, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. A SEPRAMESH IP WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. THE PATIENT SUFFERED PAIN, DISABILITY, HOSPITALIZATIONS AND ADDITIONAL SURGERIES. IT IS ALSO ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN, CHRONIC PAIN, MENTAL ANGUISH, PSYCHOLOGICAL STRESS, DEPRESSION, HAS UNDERGONE AND WILL LIKELY REQUIRE MEDICAL TREATMENTS AND OTHER FORMS OF CARE. ATTORNEY ALSO ALLEGES THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Injury; Pain

  MAUDE report 10722222 ↗
• InjuryOct 13, 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 VENTRALEX, BARD MESH (BARD FLAT MESH) AND SEPRAMESH COMPOSITE IP ON (B)(6) 2010 AND/OR (B)(6) 2012 AND/OR (B)(6) 2014 AND/OR (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2011 AND (B)(6) 2012. 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. NOTE: DATE OF IMPLANT FOR VENTRALEX WILL BE (B)(6) 2010, SINCE THE INITIAL LEGAL CLAIM IDENTIFIED THE IMPLANT DATE FOR VENTRALEX AS (B)(6) 2010. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND EXCISED. A VENTRALEX MESH (DEVICE #1) WAS PLACED USING SUTURES.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RE

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 10669656 ↗
• InjuryAug 18, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH BARD/DAVOL VENTRALEX ST HERNIA PATCH AND BARD/DAVOL SEPRAMESH IP MESH TO REPAIR A HERNIA ON (B)(6) 2014. IT IS ALLEGED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUFFERING, NECESSITATING A MESH REMOVAL AND REVISION SURGERY ON (B)(6) 2019. THE PATIENT SUFFERED SEVERE COMPLICATIONS FOLLOWING SURGERIES INCLUDING ABDOMINAL PAIN, GASTROINTESTINAL MALFUNCTION, GROTESQUE SWELLING, AND HERNIA RECURRENCE. THE PATIENT HAD PERMANENT INJURIES AND IMPAIRMENTS, INCLUDING SCARRING, DISFIGUREMENT, CHRONIC PAIN, AND SUCH FURTHER AND OTHER INJURIES. IT IS ALLEGED THAT THE PATIENT EXPERIENCED PERMANENT PHYSICAL DISABILITY, LOSS OF PHYSICAL, MENTAL AND EMOTIONAL HEALTH, SUSTAINED CERTAIN SPECIAL DAMAGES AND HAD MEDICAL TREATMENT. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Deformity/ Disfigurement; Disability; Hernia

  MAUDE report 10419499 ↗
• InjuryAug 11, 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 VENTRALIGHT ST (IMPLANT DATE NOT PROVIDED). 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: Adhesion(s); Hernia; Injury; Scar Tissue

  MAUDE report 10389840 ↗
• InjuryJul 7, 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 VENTRALIGHT ST. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH IP WHICH WAS IMPLANTED ON (B)(6) 2009. 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 10238794 ↗
• InjuryMay 22, 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 MESH (BARD FLAT MESH), BARD/DAVOL SEPRAMESH COMPOSITE IP AND BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2013 AND/OR (B)(6) 2014 AND/OR (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2014. 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 ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #1). PER OPERATIVE NOTES, ¿MIDLINE HERNIA DEFECTS WERE IDENTIFIED AND VENTRALIGHT ST USING ECHO PS (DEVICE #1) MESH WAS PLACED COVERING THE HERNIA IN THE ABDOMINAL WALL TACKED AND SUTURED IN PLACE.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA WITH RETA

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 10082393 ↗
• InjuryMay 15, 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 COMPOSIX E/X ON (B)(6) 2005 AND TWO SEPRAMESH IP COMPOSITE ON (B)(6) 2009 AND (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2009. ATTORNEY ALSO 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 10060808 ↗
• InjuryMay 5, 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/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2013. 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: Disability; Hernia; Injury; Pain

  MAUDE report 10024869 ↗
• InjuryApr 30, 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, VENTRALEX HERNIA PATCH (X2) AND VENTRALIGHT ST ON (B)(6) 2008 AND/OR (B)(6) 2015 AND/OR (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH IP AND VENTRALEX HERNIA PATCH (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; Injury

  MAUDE report 10012823 ↗
• InjuryApr 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 AN UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2009. 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: Disability; Injury; Pain

  MAUDE report 10004618 ↗