SEPRAMESHRecalls & reported problems across all models

We found 5 models of SEPRAMESH by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 342 adverse event reports in the FDA's MAUDE database, received between Aug 14, 2013 and May 29, 2026 — classified as 1 death, 336 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Defective Device” (302 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SEPRAMESH problems

SEPRAMESH models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SEPRAMESH 5959680

  Mesh, surgical, polymeric
  1 death98 reports
• SEPRAMESH 5959480

  Mesh, surgical, polymeric
  89 reports
• SEPRAMESH 5959812

  Mesh, surgical, polymeric
  87 reports
• SEPRAMESH 5959360

  Mesh, surgical, polymeric
  60 reports
• SEPRAMESH 5959124

  Mesh, surgical, polymeric
  8 reports

Recent SEPRAMESH adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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): 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, ¿TW

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24379420 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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