SEPRAMESH 5959480Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00801741031816), received between Nov 22, 2017 and May 29, 2026 — classified as 87 injuries, 2 malfunctions.

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 89 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2018- PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN LEFT INGUINAL REGION AND WAS REDUCED. A KUGEL PATCH (DEVICE 1) WAS PLACED INTO PREPERITONEAL SPACE AND WAS SUTURED¿. (B)(6) 2018- PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXPLANT OF KUGEL PATCH (DEVICE 1), IMPLANT OF SEPRAMESH IP (DEVICE 2). PER OP NOTES, ¿A HERNIA SAC WAS IDENTIFIED IN THE LEFT INGUINAL REGION AND WAS DISSECTED. THE PREVIOUSLY PLACED MESH WAS IDENTIFIED AND NOTED TO BE MEDIALLY SEPARATED FROM COOPER¿S LIGAMENT AND THE PUBIC TUBERCLE. THE KUGEL PATCH (DEVICE 1) WAS TRIMMED MEDIALLY AND A SEPRAMESH IP (DEVICE 2) WAS INSERTED INTO ABDOMINAL SPACE AND TACKED¿. (B)(6) 2019 TO (B)(6) 2019- PATIENT HAD BILATERAL LEG PAIN DUE TO COMPRESSED NERVE AS A RESULT OF MESH MIGRATION.

  Patient problems: Hernia; Pain

  MAUDE report 25334090 ↗
• InjuryMar 31, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿THE OLD SCAR WAS REMOVED. THE HERNIA SAC WAS IDENTIFIED AND REDUCED. A SEPRAMESH IP (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED USING PROLENE SUTURES.¿ ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF SEPRAMESH IP (DEVICE 1) AND IMPLANT OF SEPRAMESH IP (DEVICE 2) AND PERFIX PLUG (DEVICE 3). PER OP NOTES, ¿THE SCAR TISSUE FROM PREVIOUS INCISIONAL HERNIA IN EPIGASTRIUM WAS EXCISED. THE MESH WAS IDENTIFIED AND TORN AWAY FROM THE FASCIA. THE MESH (DEVICE 1) WAS EXCISED. A SEPRAMESH IP (DEVICE 2) WAS PLACED AND SUTURED. AN INDIRECT HERNIA SAC WAS IDENTIFIED ON RIGHT GROIN AND REDUCED. A PERFIX PLUG (DEVICE 3) WITH ONLAY PATCH WAS PLACED AND SUTURED.¿ (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿A LARGE RECURRENT DEFECT WAS IDENTIFIED AND CONTAINS OMENTUM. THE OMENTUM WAS REDUCED. THE PRIOR MESH (DEVICE 2) WAS N

  Patient problems: Hernia

  MAUDE report 24744835 ↗
• InjuryMar 31, 2026Patient-Device Incompatibility

  PER INFORMATION RECEIVED, ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OPERATIVE NOTES, "LEFT SLIGHTLY INFERIOR TO THE UMBILICUS, A HERNIA SAC WAS NOTED AND REDUCED. THE SAC WAS DISSECTED FROM THE SURROUNDING TISSUES. THE FASCIAL DEFECT WITH PRIOR SYNTHETIC MESH PULLED AWAY FROM LATERAL ABDOMINAL WALL WAS NOTED. ADHESIONS BETWEEN PRIOR MESH AND OMENTUM WAS REDUCED. A SEPRAMESH IP (DEVICE 1) WAS PLACED OVER THE DEFECT OVERLAPPING THE PRIOR SYNTHETIC MESH AND SUTURED BENEATH THE SYNTHETIC MESH. THE FASCIA WAS CLOSED AND REAPPROXIMATED WITH SUTURES." ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE 2). PER OPERATIVE NOTES, "THE SCAR IN THE MID-ABDOMEN WAS REDUCED AND HERNIA SAC CONTAINING HERNIATED OMENTUM AND SMALL INTESTINE WAS RESECTED. TWO FASCIAL DEFECTS WERE CONNECTED INTO ONE FASCIAL DEFECT AND PRIOR MESH (DEVICE 1) ADHERENT TO THE ANTERIOR ABDOMINAL WALL WAS NOTED. THE FASCIAL DEFECT WAS REDUCED AND REAPPROXIMATED WITH SUTURES. A VENTRIO ST MESH (DEVICE 2) WAS PLACED BENEATH

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

  MAUDE report 24739792 ↗
• InjuryMar 13, 2026Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A HYBRID REPAIR OF VENTRAL WALL ABDOMINAL HERNIA, UMBILICAL HERNIA WITH IMPLANT OF A SEPRAMESH IP MESH AND A RIGHT SALPINGO OOPHORECTOMY PERFORMED ON (B)(6) 2022. COMPLAINANT REPORTS THAT THE PATIENT HAS BEEN EXPERIENCING ABDOMINAL PAIN, JOINT PAIN, AND INCREASED BACK PAIN SINCE SHE HAD HER HERNIA REPAIR IN 2022. THE PATIENT ALSO FELT OCCASIONAL REDNESS AT THE MESH SITE AND FACE. PATIENT ATTRIBUTES SYMPTOMS TO MESH AND WOULD LIKE TO HAVE ALLERGY TESTING PERFORMED. PATIENT HAS NOT HAD ANY TREATMENTS PROVIDED AT THIS TIME. ADDENDUM: REACTIVITY TESTING HAS BEEN PERFORMED AND AS REPORTED THE RESULTS WERE NEGATIVE FOR AN ALLERGIC RESPONSE TO THE MESH SAMPLE.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 24593794 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012: PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED AWAY FROM SURROUNDING TISSUES. THE HERNIATED CONTENTS WERE PERITONEAL FAT WAS DISSECTED AWAY AND REMOVED. ALL THE ADHESIONS WERE CLEARED. A SEPRAMESH IP (DEVICE 1) WAS TRIMMED AND PLACED IN THE DEFECT AND SEWN USING SUTURES.¿ (B)(6) 2012: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 2). PER OP NOTES, ¿THE FASCIAL DEFECTS IN THE MIDDLE OF THE ABDOMEN ABOVE AND BELOW THE PREVIOUS REPAIR. THE PREVIOUS MESH WAS INTACT. SEVERAL ADHESIONS OF THE OMENTUM TO ABDOMINAL WALL WERE LYSED. THE MULTIPLE DEFECTS WERE NOTED AND REDUCED. A SEPRAMESH IP (DEVICE 2) WAS TRIMMED AND PLACED TO COVER ALL THE DEFECTS AND SECURED USING SUTURES. THE MESH WAS TACKED USING FIXATION DEVICE.¿ (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RECURRENT MULTIPLE INCISIONAL OR VENTRAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF SEPRAMESH IP (DEVICE 1 AND 2) AND IMPLANT OF SEPRAMESH IP (DEVICE 3 AND 4). PER OP NOTES

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24379432 ↗
• InjuryJan 9, 2026Material Deformation

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, "THE HERNIA WAS NOTED IN THE LOWER PORTION OF THE ABDOMEN. A SEPRAMESH IP (DEVICE 1) WAS PLACED TO THE ANTERIOR ABDOMINAL WALL USING SUTURES." ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 2) AND LYSIS OF ADHESIONS. PER OP NOTES, "A VERTICAL MIDLINE INCISION WAS MADE TO THE PRIOR SCAR, EXTENSIVE ADHESIOLYSIS WAS PERFORMED. A SEPRAMESH IP (DEVICE 2) WAS PLACED USING PROLENE SUTURES. ONCE THE MESH WAS IN PLACE, THE SUPERIOR ASPECT OF OLD HERNIA SITE WAS CLOSED WITH ADDITIONAL PROLENE SUTURES." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3) AND LYSIS OF ADHESIONS. PER OP NOTES, "EXTENSIVE LYSIS OF ADHESIONS WITHIN THE HERNIA SAC TO FREE THE BOWEL. IDENTIFIED THE PRIOR MESH (DEVICE 1 AND 2), IT APPEARED TO HAVE FOLDED UP ON ITSE

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

  MAUDE report 24018308 ↗
• InjuryNov 14, 2025Migration; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2008 ¿ PATENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS CLOSED AND PREPERITONEAL SPACE WAS DEVELOPED. A SEPRAMESH IP (DEVICE 1) WAS PLACED IN THE STANDARD POSITION AND TRANSFIXED WITH SUTURES.¿ ON (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 2). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED, AND THE RIGHT SIDE OF THE MESH (DEVICE 1) HAD PULLED AWAY FROM THE FASCIA AND CREATED A DEFECT WHICH ALLOWED RECURRENT HERNIA TO APPEAR. A PLANE WAS CREATED ABOVE THE PREVIOUS MESH (DEVICE 1) AND A SEPRAMESH IP (DEVICE 2) WAS PLACED IN THE INTRA-ABDOMINAL POSITION WITH THE SMOOTH AREA TOWARDS THE BOWEL AND TRANSFIXED USING SUTURES.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESH (DEVICE 1, 2). PER OP NOTES, ¿THE MESH (DEVICE 1, 2) INCORPORATED INTO HERNIA SAC WAS DISSECTED DOWN. THERE WAS MORE (DEVICE 1, 2) MESH ON THE ANTERIOR ABDOMINAL WALL SUPERIORLY ADHERENT TO OMENTUM. ADHE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23553278 ↗
• InjuryJul 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH TWO INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1, DEVICE #2). PER OP NOTES, ¿A SEPRAMESH IP (DEVICE #1) WAS PLACED TO ANTERIOR ABDOMINAL WALL AND SECURED USING TACKER. ANOTHER PIECE OF SEPRAMESH IP (DEVICE #2) WAS PLACED TO LEFT LOWER QUADRANT HERNIA DEFECT AND TACKED WITH SORBAFIX.¿ ON (B)(6) 2012 ¿ PATIENT HAD ABDOMINAL PAIN AND DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST (DEVICE #3). PER OP NOTES, ¿EXTENSIVE MIDLINE AND LEFT LOWER QUADRANT ADHESIONS NOTED TO THE UNDERSURFACE OF THE PRIOR MESH (DEVICE #1, #2) WAS TAKEN DOWN. HERNIA DEFECT WAS NOTED IN THE MIDLINE. A VENTRALIGHT ST (DEVICE #3) WAS PLACED INTO ANTERIOR ABDOMINAL WALL AND TACKED USING SORBAFIX.¿ ON (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH WOUND INFECTION THEREBY UNDERWENT INCISION AND DRAINAGE OF WOUND INFECTION AND PURULENT DRAINAGE WAS NOTED IN MID ABDOMEN. ON (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INFECTED VENTRAL HERNIA MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE #1, #2, #3) AND IMPLANT OF

  Patient problems: Adhesion(s); Scar Tissue

  MAUDE report 22455755 ↗
• MalfunctionApr 16, 2025Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, WHEN STAFF OPENED THE OUTER BOX OF THE SEPRAMESH IP MESH THE INNER PACKAGE WAS FOUND TO BE DAMAGED. IT WAS REPORTED THAT THEY DID NOT CONTINUE TO USE THE PRODUCT FOR FEAR OF CONTAMINATION. ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21851490 ↗
• InjuryMar 28, 2025Defective Device; Patient-Device Incompatibility; Migration; Defective Device; Patient-Device Incompatibility; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2012. 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: Fistula; Hernia; Insufficient Information; Nerve Damage; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 21719947 ↗
• InjuryFeb 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, SEROMA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1 & #2) ON . PER OPERATIVE NOTES, ¿AT LOWER ANTERIOR ABDOMINAL WALL, THERE WAS A PIECE OF POLYPROPYLENE MESH AS AN INLAY TO THE MEDIAL BORDER OF THE RIGHT RECTUS MUSCLE DOWN ABOUT HALFWAY BETWEEN THE PATIENT'S UMBILICUS AND PUBIS. A LARGEST DEFECT LATERAL TO THE STRIP OF POLYPROPYLENE MESH HAD INFLAMMATORY ADHESIONS, THICK HERNIA SAC WERE TAKEN DOWN. A PIECE OF SEPRAMESH IP (DEVICE #1) WAS PLACED INTRA-ABDOMINALLY AND THE INFERIOR BORDER OF THE MESH WAS FIXED TO COOPER LIGAMENT AND THE PUBIC TUBERCLE USING TACKERS. THE MEDIAL BORDER OF THE MESH WAS FIXED TO THE LATERAL BORDER OF THE RIGHT RECTUS. SUPERIORLY, THE MESH WAS FIXED WITH FASCIAL FIXATION SUTURES JUST ABOVE THE LEFT ANTERIOR SUPERIOR ILIAC SPINE. THE UMBILICAL HERNIA WAS REPAIRED USING A PIECE OF SEPRAMESH IP (DEVICE #2) AND SECURED WITH TACKS. THE SEROMA WAS DRAINED.¿ (NOTE: THE MESH PREVIOUSLY PLACED WAS UNKNOWN.) (B)(6) 2011- PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT REMOVAL OF SEPRAMESH IP (DEVICE #2) AND IMPLANT OF SEPRA

  Patient problems: Obstruction/Occlusion; Seroma

  MAUDE report 21455889 ↗
• InjuryFeb 13, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESHES (DEVICE #1 & #2). PER OPERATIVE NOTES, "ON THE RIGHT SIDE, THE HERNIA SAC WAS IDENTIFIED AND DISSECTED OUT THE DIRECT HERNIA. ATTENTION WAS GIVEN TO LEFT SIDE; SOME SCARRING WAS NOTED AND A HERNIA WAS NOTED WITHIN THE MUSCLES OF ANTERIOR ABDOMINAL WALL. A 3DMAX MESH (DEVICE #1 & #2) WAS FOLDED AND PLACED IN PREPERITONEAL SPACE. SIMILAR PROCEDURE WAS DONE ON RIGHT SIDE. THE UMBILICAL HERNIA WAS IDENTIFIED AND FIXED BY PUSHING THE OMENTUM BACK AND SUTURED." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH SUPRAUMBILICAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #3). PER OPERATIVE NOTES, "THE FASCIAL EDGES WERE IDENTIFIED AND DISSECTED FREE AND THE HERNIATED TISSUE WAS PUT BACK IN PERITONEAL CAVITY. A VENTRALEX ST (DEVICE #3) WAS PLACED AND SUTURED TO THE FASCIAL EDGES." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN AND LAPAROSCOPIC REPAIR WITH EXPLANT OF VENTRALEX ST (DEVICE #3) AND IMPLANT OF SEPRAMESH IP (DE

  Patient problems: Hernia; Pain

  MAUDE report 21371807 ↗
• InjurySep 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT INCISIONAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A SEPRAMESH IP. PATIENT DEVELOPED POSTOPERATIVE INTESTINAL FISTULA DEFECT, AND IT REQUIRED SECONDARY SURGERY.

  Patient problems: Fistula

  MAUDE report 20145806 ↗
• InjuryJun 6, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2021 - PATIENT WITH HISTORY OF PELVIC PROLAPSE, RECTOCELE, EROSION OF PREVIOUSLY IMPLANTED URETHRAL MESH AND VAGINAL MESH WAS DIAGNOSED WITH DYSPAREUNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC RECTOPEXY WITH THE IMPLANT OF SEPRAMESH IP. PER OPERATIVE NOTES, ¿PRIOR COLPOPEXY MESH AND SUBURETHRAL MESH SLINGS WERE ENCOUNTERED AND DISSECTED. RECTOPEXY WAS PERFORMED USING A TRIMMED SEPRAMESH IP, WHICH WAS INTRODUCED INTO THE PELVIC CAVITY AND SECURED TO THE DISTAL-MOST RECTUM USING SUTURES.¿ (B)(6) 2021 - PATIENT HAD LOWER ABDOMEN TIGHTNESS DURING HOSPITAL VISIT. ALSO, FEELS MESH NEAR THE ANAL OPENING AND SOME BOWEL BLOCKAGE. (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH PELVIC PAIN, PELVIC FLOOR DYSFUNCTION THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPY WITH THE EXPLANT OF SEPRAMESH IP AND A SIGMOIDOSCOPY. PER OPERATIVE NOTES, ¿THE SMALL BOWEL WAS REMOVED FROM THE PELVIS. THE MESH WAS DISSECTED SUPERIORLY AND CONTINUED TO INFERIORLY. ALL THE SUTURES AND MESH WERE REMOVED COMPLETELY."

  Patient problems: Adhesion(s); Pain

  MAUDE report 19474479 ↗
• InjuryDec 28, 2023Defective 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) 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 REVISION SURGERIES 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: Hernia; Insufficient Information; Pain

  MAUDE report 18407682 ↗
• MalfunctionNov 28, 2023Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING PARASTOMAL HERNIA REPAIR ON (B)(6) 2023, AN EXPIRED SEPRAMESH IP MESH WAS INADVERTENTLY IMPLANTED INTO THE PATIENT. THE LABELED EXPIRATION DATE OF THE IMPLANT IS 28-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220583 ↗
• InjurySep 7, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA MESH REPAIR WITH IMPLANT OF A SEPRAMESH IP. IT WAS REPORTED THAT POST IMPLANT, THE PATIENT DEVELOPED SMALL INTESTINAL FISTULA AND ABDOMINAL INFECTION AND UNDERWENT ADDITIONAL SURGERY. ADDENDUM: AS REPORTED, PATIENT UNDERWENT REPAIR USING SEPRAMESH IP FOLLOWING DIAGNOSIS OF INTESTINAL OBSTRUCTION ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND OPERATION FOR SMALL BOWEL FISTULA (JEJUNAL FISTULA REPAIR) ON (B)(6) 2023 DURING WHICH THE MESH WAS REMOVED. AS REPORTED, THE PATIENT IS IN GOOD HEALTH CONDITION AFTER THE SECOND OPERATION.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 17699693 ↗
• InjuryNov 17, 2022Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES: THE PATIENT WAS IMPLANTED WITH BARD/DAVOL SEPRAMESH IP AND BARD MESH (BARD FLAT MESH) (THE "PRODUCT"). THE PATIENT WAS IMPLANTED WITH BARD/DAVOL SEPRAMESH IP ON (B)(6) 2015 IN THE COURSE OF AN INCISIONAL HERNIA REPAIR SURGERY. IT IS ALLEGED THAT THE PATIENT SUFFERED THE DEVELOPMENT OF MESH FAILURE, HERNIA RECURRENCE AND CHRONIC PAIN. IT IS ALSO ALLEGED THAT ON OR ABOUT (B)(6) 2015, THE PATIENT UNDERWENT CORRECTIVE REVISION SURGERY AND ON OR ABOUT (B)(6) 2016, THE PATIENT UNDERWENT ANOTHER CORRECTIVE REVISION SURGERY. IT IS ALLEGED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT ANOTHER CORRECTIVE REVISION SURGERY WITH BARD MESH (BARD FLAT MESH). 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 THE PLAINTIFF SUFFERED PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT. ATTORNEY ALSO ALLEGES THAT THE PLAINTIFF SUFFERING, PSYCHOLOGICAL AND EMOTIONAL INJURIES AND PERMANENT PHYSICAL DISABILITY. IT IS ALLEGED THAT THE PLAINTIFF CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT. IT IS ALS

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

  MAUDE report 15813927 ↗
• InjuryMay 30, 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) 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; Pain

  MAUDE report 14539300 ↗
• InjuryMar 23, 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) 2016. 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Scar Tissue

  MAUDE report 13863104 ↗
• InjuryMar 15, 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 AND DAVOL PLUG MESH (X2) ON (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. 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 13769293 ↗
• 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 17-AUG-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, DIA

  Patient problems: Hernia; Obstruction/Occlusion; Pain

  MAUDE report 12741178 ↗
• InjuryJun 1, 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) 2009. 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; Insufficient Information

  MAUDE report 11914569 ↗
• InjuryMar 8, 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 AND VENTRALIGHT ST ON (B)(6) 2018 AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 11433389 ↗
• InjuryFeb 8, 2021Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH AND SEPRAMESH IP ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Seroma; Unspecified Infection

  MAUDE report 11291007 ↗