SEPRAMESH 5959680Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00801741031823), received between Aug 14, 2013 and Apr 27, 2026 — classified as 1 death, 96 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (85 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 98 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: ON (B)(6) 2005: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, "THE HERNIA RENT WAS NOTED IN MIDLINE. A LARGE COMPOSIX KUGEL PATCH (DEVICE 1) WAS PLACED IN ABDOMINAL CAVITY WITH PTFE AND SECURED USING TACKS." ON (B)(6) 2005: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA; ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 2). PER OP NOTES, "THE RECURRENCE WAS NOTED RIGHT OF MIDLINE BELOW THE UMBILICUS. ADHESION TO PREVIOUS MESH (DEVICE 1) WAS TAKEN DOWN. A LARGE SEPRAMESH IP (DEVICE 2) WAS TRIMMED IN OVAL FASHION AND PLACED INTO PERITONEAL CAVITY AND TACKED." ON (B)(6) 2019: PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OP NOTES, "THE INCISIONAL HERNIA WAS ON THE EPIGASTRIUM AT THE SITE OF PREVIOUS RIGHT SUBCOSTAL INCISION FROM OPEN CHOLECYSTECTOMY. THE INFERIORLY PLACED HERNIA MESH (DEVICE 2) FROM LOWER ABDOMINAL INCISIONAL HERNIA WAS NOTED. ADHESIONS TO THE MESH ITSELF WHICH WERE LEFT IN SITU. A VENTRIO ST MESH (DEVICE 3) W

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24996619 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA, UMBILICAL HERNIA AND LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1), VENTRALEX MESH (DEVICE 2), BARD MESH PRE-SHAPED WITH KEYHOLE (DEVICE 3) AND SEPRAMESH IP (DEVICE 4). PER OP NOTES, ¿CYSTOSCOPY WAS PERFORMED. SMALL BOWEL ADHERENT TO THE MIDLINE FROM THE FALCIFORM LIGAMENT DOWN TOWARDS THE BLADDER WAS TAKEN DOWN. THE SEROSA WAS REPAIRED WITH SUTURES. ADHESIONS BETWEEN THE SIGMOID COLON WAS REMOVED FROM THE INCARCERATED LEFT INGUINAL HERNIA. A BARD MESH PRE-SHAPED WITH KEYHOLE (DEVICE 3) AND A COMPOSIX E/X (DEVICE 1) WERE PLACED IN THE LEFT INGUINAL AREA AND SECURED WITH SUTURES. THE UMBILICAL HERNIA WAS THEN CLOSED WITH A VENTRALEX MESH (DEVICE 2). A SEPRAMESH IP (DEVICE 4) WAS PLACED INTRAABDOMINALLY FOR THE REPAIR OF VENTRAL HERNIA AND STAPLED TO THE ANTERIOR ABDOMINAL WALL.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL FISTULA TO THE OVERLYING MESH THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 2) AND SEPRAMESH IP (DEVICE 4). PER OP NOTES, ¿AN INCISION WAS MADE IN THE LOWER ABDOMEN BELOW THE MESH. THE MESH

  Patient problems: Adhesion(s); Bowel Perforation; Fistula

  MAUDE report 24377622 ↗
• InjuryJan 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿THE HERNIA WAS LOCATED IN UPPER MIDLINE. A PIECE OF SEPRAMESH IP (DEVICE 1) WAS CUT INTO CIRCULAR PATTERN AND UTILIZED TO OVER THE FASCIAL DEFECT USING SORBAFIX TACKS.¿ (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF SEPRAMESH IP (DEVICE 2). PER OP NOTES, ¿THE HERNIA SITE WAS LOCATED IN THE MIDLINE ABOVE THE UMBILICUS. THERE WAS SOME OLD MESH (DEVICE 1) HAD EVENTRATED UP INTO THE HERNIA SAC. THE OLD MESH (DEVICE 1) WAS REMOVED. A FEW ADHESIONS WERE LYSED. BILATERAL MUSCLE FLAPS WERE RAISED. A SEPRAMESH IP (DEVICE 2) WAS PLACED IN RETROMUSCULAR POSITION AND SUTURED.¿ (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OP NOTES, ¿THE HERNIA WAS LOCATED IN THE MIDLINE ABOUT AT THE LEVEL OF THE UMBILICUS. THE HERNIA RECURRED JUST DEEPER TO THE LEVEL OF THE OLD MESH (DEVICE 2) WAS INTACT WHICH WAS HOLDING

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24207285 ↗
• InjuryDec 26, 2025Migration; Migration

  ON (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿MULTIPLE HERNIA DEFECT IN MIDLINE WERE ENCOUNTERED. THE SEPRAMESH IP (DEVICE 1) WAS LAID ON THE TOP OF FASCIA AND SUTURED.¿ ON (B)(6) 2013 ¿ PATIENT HAD PAIN AND WAS DIAGNOSED WITH INCARCERATED VENTRAL AND INCISIONAL HERNIA; UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX PATCH (DEVICE 2). PER OP NOTES, ¿PREVIOUS UPPER MIDLINE ABDOMINAL INCISION EXTENDED TO THE SUPERIOR ASPECT OF THE UMBILICUS. THE SCAR TISSUE WAS TAKEN OFF. THE HERNIA SAC WAS NOTED WITH SOME NECROTIC OMENTUM. THERE WERE SOME ADHESIONS TO THE ABDOMINAL WALL WITH THE SMALL BOWEL. A SMALL UMBILICAL HERNIA WAS NOTED. A VENTRALEX MESH (DEVICE 2) WAS PLACED UNDERLAY AND AFFIXED TO THE ABDOMINAL WALL USING SUTURE.¿ (NOTE: THERE WAS NO MENTION/VISUALIZATION OF DEVICE 1 IN THIS PROCEDURE) ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿THE HERNIA SAC WAS MORE TO THE LEFT OF THE MIDLINE INCISION. THE PREVIOUS MESH REPAIR INFERIOR TO THE HERNIA DEFE

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

  MAUDE report 23897326 ↗
• InjuryJul 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH TWO INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1) AND VENTRALEX MESHES (DEVICE #2, #3). PER OP NOTES, ¿HERNIA IN THE MIDLINE OF THE ABDOMEN ADJACENT TO UMBILICUS WAS NOTED. A COMPOSIX E/X MESH (DEVICE #1) WAS PLACED THE DEFECT AND SUTURED. THEN, SECOND HERNIA WAS NOTED INFERIORLY WAS REPAIRED USING A VENTRALEX MESH (DEVICE #2) AND TACKED TO INFERIOR ABDOMINAL WALL. A WEAKENED POINT WAS NOTED SUPERIOR TO SECOND HERNIA WAS REPAIRED WITH ANOTHER VENTRALEX MESH (DEVICE #3) AND SUTURED.¿ (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #4). PER OP NOTES, ¿A LARGE AMOUNT OF ADHESIONS WERE NOTED IN THE MIDLINE OF ABDOMEN AND SIGNIFICANT HERNIATION NOTED IN SUPRAUMBILICAL AREA. A LARGE PIECE OF SEPRAMESH IP (DEVICE #4) WAS PLACED INTO THE SUPRAUMBILICAL HERNIA DEFECT AND TACKED USING SORBAFIX.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INFECTED MESH AND ENTEROCUTANEOUS FISTULA, ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE #1, #2, #3, #4). PE

  Patient problems: Fistula; Purulent Discharge; Unspecified Infection

  MAUDE report 22492552 ↗
• InjuryJun 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OP NOTES, "A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OP NOTES, "A VENTRALEX MESH (DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (DEVICE #1) AND VENTRALEX MESH (DEVICE #2) AND IMPLANT OF SEPRAMESH IP (DEVICE #3). PER OP NOTES, "ADHESIONS WERE TAKEN DOWN. THE MESHES (DEVICE #1 & #2) WERE REMOVED AND A SEPRAMESH IP (DEVICE #3) WAS PLACED AND SUTURED." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #4). PER OP NOTES, "A VENTRALIGHT ST USING ECHO PS (DEVICE #4) WAS PLACED AND TACKED."

  Patient problems: Hernia

  MAUDE report 22334482 ↗
• InjuryJun 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006 ¿ PATIENT WITH A COMPLEX HISTORY FOR COLOSTOMY, PERINEAL PROBLEMS WAS DIAGNOSED WITH PARACOLOSTOMY HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COLLAMEND MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND REPAIRED WITH COLLAMEND MESH (DEVICE #1) AND SUTURED.¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT PARACOLOSTOMY HERNIA, THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE HERNIA SAC WITH FLUID WAS REDUCED AND SUTURED.¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC PARACOLOSTOMY HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #2). PER OPERATIVE NOTES, ¿A LARGE SYMPTOMATIC PARACOLOSTOMY HERNIA WAS IDENTIFIED AND DISSECTED. A COMPOSIX KUGEL MESH (DEVICE #2) WAS PLACED AROUND THE DEFECT AND SUTURED.¿ (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH RECURRENT PARACOLOSTOMY HERNIA WITH COLONIC OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH SEGMENTAL COLON RESECTION. PER OPERATIVE NOTES, ¿THE PARACOLOSTOMY HERNIA WAS IDENTIFIED ABOVE THE PREVIOUSLY PLACED MESH. THE HERNIA DEFECT WAS CLOSED WITH SUTURES.¿ (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INFECTED MESH IN

  Patient problems: Abdominal Pain

  MAUDE report 22164019 ↗
• InjuryJun 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH LEFT LUMBAR HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL (DEVICE #1). PER OP NOTES, "A COMPOSIX KUGEL (DEVICE #1) WAS PLACED AND TACKED." ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH ILIOINGUINAL NERVE ENTRAPMENT WITH RETROPERITONEAL SCARRING, PAIN THEREBY UNDERWENT DIVISION OF LEFT ILIOINGUINAL NERVE. ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT LUMBAR HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX KUGEL (DEVICE #2). PER OP NOTES, "THE PREVIOUSLY PACED MESH (DEVICE #1) APPEARED TO BE INTACT. A COMPOSIX KUGEL (DEVICE #2) WAS PLACED AND SUTURED." ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INFECTED MESH (DEVICE #1), HEMATOMA THEREBY UNDERWENT PARTIAL REMOVAL OF COMPOSIX KUGEL (DEVICE #1). PER OP NOTES, "THE DENSELY ADHERENT COMPOSIX KUGEL (DEVICE #1) WAS DISSECTED AND REMOVED IN TWO PIECES." ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT LUMBAR HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF COMPOSIX KUGEL (DEVICE #1) AND IMPLANT OF SEPRAMESH IP (DEVICE #3). PER OP NOTES, "THE PREVIOUSLY PLACED MESH (DEVICE #1) APPEARED TO BE BUCKL

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22160565 ↗
• InjuryMar 11, 2025Defective Device; Patient-Device Incompatibility; Migration; Defective Device; Patient-Device Incompatibility; Migration

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH SEPRAMESH IP (CAT #5959680, LOT #HUUL0986) ON (B)(6) 2011 THEREBY UNDERWENT VENTRAL HERNIA REPAIR. IT WAS ALSO ALLEGED, THAT THE PATIENT EXPERIENCED WOUND INFECTION, DEHISCENCE AND NECROSIS THEREBY UNDERWENT EXPLORATORY LAPAROTOMY PROCEDURE, WOUND WASHOUT AND EXCISION OF BRIDGING MESH ON OR ABOUT (B)(6) 2023. IT IS ALLEGED THAT THE SURGEON NOTED "THE PREVIOUSLY PLACED MESH WAS SOMEWHAT PULLED AWAY FROM THE FACIAL EDGES AND WAS THEREFORE EXCISED. AS ALLEGED, THE PATIENT EXPERIENCED AND/OR CURRENTLY EXPERIENCES ADDITIONAL SURGICAL INTERVENTION, RECURRENCE, CHRONIC PAIN, WHICH HAVE IMPAIRED DAILY ACTIVITIES. 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 DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Necrosis; Pain; Wound Dehiscence; Wound Infection

  MAUDE report 21571592 ↗
• InjurySep 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT AN ABDOMINAL WALL HERNIA REPAIR TREATED WITH IPOM (INTRAPERITONEAL ONLAY MESH) SURGERY USING THE SEPRAMESH IP IN (B)(6) 2024. AFTER 3 MONTHS, IT WAS NOTED THAT THE PATIENT DEVELOPED A MASS IN THE RIGHT LOWER ABDOMEN REQUIRING A SECOND SURGERY.

  Patient problems: Subcutaneous Nodule

  MAUDE report 20145614 ↗
• InjuryMay 16, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT ABDOMINAL WALL HERNIA REPAIR SURGERY BY VIDEO LAPAROSCOPY IN WHICH SEPRAMESH IP WAS IMPLANTED WITH THE USE OF A SORBAFIX FOR FIXATION ON (B)(6) 2024. IT WAS REPORTED THAT POST IMPLANT PATIENT HAD INTESTINAL SUB-OCCLUSION AND A LOT OF PAIN IN THE RIGHT ABDOMEN AND THEREBY UNDERWENT REOPERATION ON (B)(6) 2024, IN WHICH IT WAS FOUND THE SMALL INTESTINE AND A LARGE PART OF THE GREATER OMENTUM HAD ADHERED TO THE NON-STICK PART OF THE MESH. AS REPORTED, ALL THE CONTENTS ADHERED TO THE MESH WERE REMOVED AND THE MESH WAS REMOVED FROM THE PATIENT.

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

  MAUDE report 19331014 ↗
• InjuryFeb 6, 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 IP ON (B)(6) 2013. 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); Fistula; Insufficient Information; Unspecified Infection

  MAUDE report 18649223 ↗
• InjuryJul 13, 2023Defective 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 COMPOSITE IP ON (B)(6) 2011. 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: Abscess; Adhesion(s); Bowel Perforation; Inflammation; Insufficient Information; Necrosis; Pain; Strangulation; Unspecified Infection

  MAUDE report 17314135 ↗
• InjuryJul 10, 2023Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP AND PHASIX ST ON (B)(6)2015 AND/OR (B)(6)2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. ATTORNEY ALSO ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6)2022. 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: Abscess; Adhesion(s); Erosion; Fistula; Hernia; Insufficient Information; Pain; Post Operative Wound Infection

  MAUDE report 17285942 ↗
• MalfunctionAug 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON ATTEMPTED TO IMPLANT THE BARD/DAVOL SEPRAMESH IP, IT WAS NOTED TO BE 'FRACTURED'. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209336 ↗
• InjuryFeb 9, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2006 AND SEPRAMESH COMPOSITE IP ON (B)(6) 2011. 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: Insufficient Information; Pain

  MAUDE report 13498102 ↗
• InjuryNov 24, 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) 2013. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP. PER OP NOTES, "A SEPRAMESH IP WAS PLACED AND SUTURED." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH PELVIC PAIN THEREBY UNDERWENT LAPAROSCOPIC LYSIS OF ADHESIONS. PER OP NOTES, "LYSIS OF ADHESIONS WAS PERFORMED AND THE PREVIOUS MESH WAS SEEN TO BE IN GOOD POSITION." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT MULTIPLE HERNIAS, HIATAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OP NOTES, "ADHESIONS WERE LYSED AND ALL THE DEFECTS WERE REPAIRED USING SUTURES."

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

  MAUDE report 12867090 ↗
• InjuryNov 2, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL SEPRAMESH IP. IT IS ALLEGED THAT ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH THE PRODUCT IN THE COURSE OF AN INCISIONAL HERNIA REPAIR SURGERY. IT IS ALLEGED THAT FURTHER TO THE PATIENT'S IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE, NECESSITATING FURTHER REPARATIVE SURGERY WHICH OCCURRED ON (B)(6) 2011 WHERE A BARD/DAVOL SEPRAMESH IP WAS IMPLANTED. IT IS ALLEGED THAT SUBSEQUENT TO THE SURGERY, THE PATIENT HAS CONTINUED TO SUFFER FROM CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE WHICH RESULTED IN THE PATIENT REQUIRING VARIOUS ADDITIONAL SURGERIES. 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. IT IS ALLEGED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUFFERING, INCLUDING CHRONIC PAIN. THE PATIENT HAS BEEN TREATED WITH A COURSE OF HOSPITALIZATION, DI

  Patient problems: Hernia; Obstruction/Occlusion; Pain

  MAUDE report 12741177 ↗
• InjuryAug 14, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY FOR IMPLANT OF A BARD/DAVOL SEPRAMESH IP ON (B)(6) 2011. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION OF THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF CHRONIC PAIN, INFLAMMATION, ADHESIONS AND HERNIA RECURRENCES NECESSITATING SUBSEQUENT REVISION SURGERY AND THE 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: Adhesion(s); Hernia; Pain

  MAUDE report 12322192 ↗
• InjuryJul 1, 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 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 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 12105275 ↗
• InjuryMar 10, 2021Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES PER SHORT FORM (SEE ATTACHED) THAT THE PATIENT UNDERWENT SURGERY FOR 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 ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2011. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Hernia; Insufficient Information; Pain

  MAUDE report 11452329 ↗
• InjuryMar 10, 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 UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2014 AND BARD SOFT MESH ON (B)(6) 2015. 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 11452222 ↗
• InjuryDec 29, 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 COMPOSITE MESH (COMPOSIX) ON (B)(6) 2003, SEPRAMESH COMPOSITE IP ON (B)(6) 2011, VENTRALEX ST ON (B)(6) 2017 AND VENTRALIGHT ST ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSITE MESH (COMPOSIX), SEPRAMESH COMPOSITE IP AND VENTRALEX ST. 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 11086050 ↗
• InjuryDec 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 UNSPECIFIED BARD/DAVOL COMPOSIX L/P, SEPRAMESH IP AND XENMATRIX AB ON (B)(6) 2012 AND/OR (B)(6) 2014 AND/OR (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX L/P AND 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

  MAUDE report 11017524 ↗
• InjuryNov 19, 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 IP ON (B)(6) 2017. 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

  MAUDE report 10866109 ↗