COMPOSIX 0134450Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00801741031267), received between Jan 9, 2017 and Aug 21, 2026 — classified as 44 injuries.

The most frequently reported specific device problem is “Defective Device” (37 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2008 - Patient was diagnosed with recurrent umbilical hernia thereby underwent open repair with implant of Ventralex Mesh (Device 1). Per operative notes, "A semicircular incision was made in the skin superior to the umbilicus. The hernia sac was identified and was dissected free from the deep tissue. A Ventralex Mesh (Device 1) was placed into the abdominal fascia in a tension free repair and secured it with sutures."(b)(6)2011 - Patient was diagnosed with recurrent incarcerated umbilical hernia, adhesion thereby underwent laparoscopic repair with implant of Composix LP Mesh (Device 2) and explant of Ventralex Mesh (Device 1). Per operative notes, "An incision was made around the umbilicus. The hernia sac was dissected out. There were multiple adhesions to the abdominal wall around the previous Ventralex Mesh (Device 1). Extensive lysis of adhesions was performed. The Ventralex Mesh (Device 1) was excised entirely. A Composix LP Mesh (Device 2) was placed into the abdominal wall and secured it with sutures."(b)(6)2011 - Patient was diagnosed with recurrent umbilical hernia thereby underwent open repair with implant of biological mesh. (Note: No opera

  Patient problems: Hernia; Pain

  MAUDE report 50382861 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MODIFIED KUGEL PATCH (DEVICE 1). PER OP NOTES, ¿HERNIA WAS NOTED. A MODIFIED KUGEL PATCH (DEVICE 1) WAS PLACED AND FLATTENED OUT AGAINST PREPERITONEAL SPACE. THE TAILS SUTURED DOWN TO SURROUNDING FASCIA.¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, EPIGASTRIC HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, ¿ADHESIONS WERE LYSED. THE ORIGINAL MESH (DEVICE 1) WAS IDENTIFIED, AND A DEFECT WAS NOTED TO ONE SIDE AND SECOND HERNIA DEFECT WAS ALSO NOTED. A ROUND PIECE OF COMPOSIX L/P MESH (DEVICE 2) WAS PLACED LATERALLY IN LEFT FLANK AND SECURED USING PROTACKS.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE 1, 2). PER OP NOTES, ¿THE HERNIA SAC WAS FREED UP FROM THE SUBCUTANEOUS TISSUES. ADHESIONS OF SMALL BOWEL WERE FREED UP. ALL THE MESH (DEVICE 1, 2) AND TACKS WERE REMOVED. THE FASCIAL LAYER WAS IDENTIFIED AND A PIECE OF SYNTHETIC MESH WAS PLACED AS UNDERLAY TYPE REPAIR USING SUTURES.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24697901 ↗
• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH LEFT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO COMPOSIX L/P MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿ IN THE LEFT LOWER QUADRANT, A LARGE HERNIA WITH SCAR WAS NOTED. ADHESIONS WERE LYSED AND OVAL COMPOSIX L/P MESH (DEVICE 1) WAS PLACED, AND ANOTHER CIRCULAR COMPOSIX L/P MESH (DEVICE 2) WAS PLACED AS AN ADEQUATE COVERAGE AND CONNECTED TOGETHER WITH SUTURES AND TACKS." ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT LEFT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PRIOR MESHES (DEVICE 1 AND 2) IMPLANT OF BIOLOGICAL GRAFT. PER OPERATIVE NOTES, ¿ A SMALL HERNIA SAC WAS IDENTIFIED INFERIOR TO THE MESHES (DEVICE 1 AND 2). THE MESHES (DEVICE 1 AND 2) WERE SEPARATED FROM THE ANTERIOR ABDOMINAL WALL AND COMPLETELY REMOVED. SEVERAL AREAS OF ADHESIONS WERE LYSED. THE BIOLOGICAL GRAFT WAS PLACED IN AN UNDERLAY FASHION AND SECURED TO ANTERIOR ABDOMINAL WALL WITH SUTURES.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24326890 ↗
• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "INCISION WAS MADE TO THE INFRAUMBILICALLY, A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE DEFECT USING SUTURES." (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF INFECTED MESH (DEVICE 1) AND IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, "A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED INTO THE ABDOMINAL CAVITY USING SUTURES." (B)(6) 2010 - PATIENT HAD ABSCESS. PER OP NOTES, "DISSECTION WAS CARRIED DOWN THROUGH THE SKIN AND SUBCUTANEOUS TISSUE TO THE UNDERLYING STITCH ABSCESS AND SINUS TRACT, THIS WAS EXCISED. THE PREVIOUSLY HEALED SCAR AND TISSUE ARRANGEMENT WAS DONE."

  Patient problems: Abscess; Scar Tissue

  MAUDE report 24321202 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL ABDOMINAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1) AND COMPOSIX L/P MESH (DEVICE 2). PER OPERATIVE NOTES, ¿IN THE RIGHT LOWER QUADRANT, A LARGE RECURRENT VENTRAL ABDOMINAL INCISIONAL HERNIA IN THE MIDLINE WITH SMALL BOWEL WITHIN HERNIA SAC WAS NOTED. THE SAC WAS DISSECTED AND VENTRALEX ST MESH (DEVICE 1) AND COMPOSIX L/P MESH (DEVICE 2) WAS PLACED OVER THE DEFECT AND SUTURED AROUND THE FASCIA.¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH CHRONICAL INFECTED MESH (X2), RECURRENT ABDOMINAL INCISIONAL HERNIA, SMALL BOWEL ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF INFECTED MESHES (DEVICE 1 AND 2) AND SMALL BOWEL RESECTION. PER OPERATIVE NOTES, ¿THE HERNIA SAC SURROUNDING THE SCAR TISSUES WERE REDUCED AND RECURRENT HERNIA WAS CLOSED PRIMARILY WITH SUTURES. THE ADHESIONS OF OMENTUM AND SMALL BOWEL WERE LYSED. THE INFECTED MESHES (DEVICE 1 AND 2) WAS EXCISED AND SMALL BOWEL WAS EVISCERATED OUT OF THE ABDOMEN AND RESECTED. THE MESENTERY WAS CLOSED AND REAPPROXIMATED WITH SUTURES.¿

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

  MAUDE report 23943054 ↗
• InjuryAug 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH DEVICE 1). PER OP NOTES "A VENTRALEX MESH DEVICE 1) WAS PLACED AND SUTURED." (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE EXPLANT OF VENTRALEX MESH (DEVICE 1) AND IMPLANT OF COMPOSIX L/P MESH DEVICE 2). PER OP NOTES "SOME OMENTAL ADHESIONS WERE TAKEN DOWN AND A SMALL SEROMA CAVITY WAS ENCOUNTERED. THE OLD MESH (DEVICE 1) WAS REMOVED AND A COMPOSIX L/P MESH DEVICE 2) WAS PLACED AND SUTURED." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. PER OP NOTES "A SYNTHETIC MESH WAS PLACED AND SUTURED."

  Patient problems: Hernia

  MAUDE report 22902471 ↗
• InjuryMar 4, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY. (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO COMPOSIX L/P MESH (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE ADHESIONS WERE LYSED, AND THE DEFECT WAS MEASURED. APPROPRIATE SIZE COMPOSIX L/P MESH (DEVICE #1) WAS PLACED IN THE PERITONEAL CAVITY AND STAB WOUND INCISIONS WERE MADE BRINGING THE MESH UP THE ABDOMINAL WALL USING SUTURES AND TACKS. A SECOND MESH, COMPOSIX L/P MESH (DEVICE #2), THAT WAS PLACED IN THE PERITONEAL CAVITY. THIS MESH WAS TACKED DEEP TO THE FASCIA ABOVE THE DEFECT SUPERIORLY AND ONCE THIS WAS IN PLACE, THIS MESH WAS SUTURED TO THE OLD MESH TO CREATE ONE LARGE MESH, AND THIS WAS DONE USING SUTURES.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL HEMATOMA AND RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF COMPOSIX L/P MESHES (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THERE WAS SCAR TISSUE, WHICH WAS EXCISED. THERE WAS CONSIDERABLE INFLAMMATION AT THE SITE OF THE MESH. THERE WERE SOME ADHESIONS INVOLVING OMENTUM. THEN THERE WAS HEMATOMA AND BULGING OF THE ABDOMINAL WALL WITH THE MESH WAS IN PLACE. THE MESH (DEVICE #1

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

  MAUDE report 21512183 ↗
• InjuryApr 8, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA RECURRENCE WAS NOTED, AND SAC WAS EXCISED. ADHESIONS WERE TAKEN DOWN. A LARGE UMBILICAL VENTRALEX MESH (DEVICE #1) WAS USED AND SUTURED.¿. (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX MESH (DEVICE #1) AND IMPLANT OF COMPOSIX L/P MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA WAS VERY SCARRED AND THE BOWEL FREED FROM THE HERNIA SAC. THE VENTRAIEX MESH (DEVICE #1) WAS ADHERENT AT THE SUPERIOR ASPECT OF THE WOUND AND THE MESH WAS REMOVED. A COMPOSIX L/P MESH (DEVICE #2) WAS PLACED INTO THE ABDOMINAL WALL AND SUTURED.¿. (B)(6) 2012 - PATIENT PRESENTS WITH ABDOMINAL PAIN. (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, ENTEROCUTANEOUS FISTULA AND ERYTHEMA WITH SOME WOUND DRAINAGE THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF COMPOSIX L/P MESH (DEVICE #2) AND SMALL BOWEL RESECTION. PER OPERATIVE NOTES, ¿THE MESH WAS ENCOUNTERED AND

  Patient problems: Abdominal Pain; Adhesion(s); Erythema; Fistula; Hernia; Wound Dehiscence

  MAUDE report 19059370 ↗
• InjuryMar 13, 2024Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE #1). PER OPERATIVE NOTES, "LYSIS OF ADHESIONS WAS REQUIRED AND THE DEFECT WAS IDENTIFIED. A COMPOSIX L/P MESH (DEVICE #1) WAS PLACED THROUGH THE MIDDLE OF THE DEFECT AND SECURED.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE #2). PER OPERATIVE NOTES, "DENSE ADHESIONS NOTED TO THE PREVIOUSLY PLACED MESH WERE LYSED. A COMPOSIX L/P MESH (DEVICE #2) WAS SECURED INTO THE PERITONEAL CAVITY, BROUGHT OUT THROUGH THE DEFECT WITH SUTURE AND SECURED." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE #3). PER OPERATIVE NOTES, "HERNIA DEFECT WAS EASILY REDUCED. A SMALL SECTION OF SEPRAMESH IP (DEVICE #3) WAS SECURED INTO THE PERITONEAL CAVITY, SEWN CIRCUMFERENTIALLY INTO THE DEFECT AND SUTURED." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL & LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH MESH REMOVAL

  Patient problems: Adhesion(s); Hernia

  MAUDE report 18892894 ↗
• InjuryMar 13, 2024Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE #1). PER OPERATIVE NOTES, "LYSIS OF ADHESIONS WAS REQUIRED AND THE DEFECT WAS IDENTIFIED. A COMPOSIX L/P MESH (DEVICE #1) WAS PLACED THROUGH THE MIDDLE OF THE DEFECT AND SECURED.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE #2). PER OPERATIVE NOTES, "DENSE ADHESIONS NOTED TO THE PREVIOUSLY PLACED MESH WERE LYSED. A COMPOSIX L/P MESH (DEVICE #2) WAS SECURED INTO THE PERITONEAL CAVITY, BROUGHT OUT THROUGH THE DEFECT WITH SUTURE AND SECURED." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE #3). PER OPERATIVE NOTES, "HERNIA DEFECT WAS EASILY REDUCED. A SMALL SECTION OF SEPRAMESH IP (DEVICE #3) WAS SECURED INTO THE PERITONEAL CAVITY, SEWN CIRCUMFERENTIALLY INTO THE DEFECT AND SUTURED." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL & LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH MESH REMOVAL

  Patient problems: Adhesion(s); Hernia

  MAUDE report 18892818 ↗
• InjuryJan 3, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE #1). PER OPERATIVE NOTES, ¿AFTER REMOVAL OF ADHERENT LOOPS OF BOWEL AND REDUCTION OF INCARCERATED SMALL BOWEL, THE HERNIA DEFECT WAS MEASURED. A CIRCULAR COMPOSIX L/P MESH (DEVICE #1) WAS PLACED IN THE PERITONEAL CAVITY, SECURED TO THE ANTERIOR ABDOMINAL WALL USING SUTURES AND HERNIA TACKER.¿ (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH SUPRAUMBILICAL MIDLINE INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿SOME INCARCERATED OMENTUM WAS REDUCED INTO THE PERITONEAL CAVITY. HERNIA SAC WAS EXCISED. A CIRCULAR HARD VENTRALEX HERNIA PATCH (DEVICE #2) WAS PLACED BELOW FASCIA AND SUTURED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN, CHRONIC CHOLECYSTITIS, CHOLELITHIASIS, CHRONIC RECURRENT GASTRO JEJUNOSTOMY CONTAINED PERFORATION AND RECURRENT GASTRIC FISTULAS THEREBY UNDERWENT LAPAROSCOPIC-OPEN REPAIR WITH PARTIAL REMOVAL OF VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿I TOOK DOWN ADH

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

  MAUDE report 18441501 ↗
• InjuryJan 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER PROVIDED MEDICAL RECORDS: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA AND WAS SCHEDULED FOR REPAIR. PER OPERATIVE NOTES "HE WAS NOTED TO HAVE A LARGE INCARCERATED MESH (NO PRODUCT IDENTIFIERS PROVIDED) IN THE ABDOMINAL WALL SUBCUTANEOUS SPACE. THEN PLACED A PIECE OF BARD COMPOSIX LP MESH (DEVICE #1) OF CIRCULAR SHAPE MEASURING 11.4 CM IN DIAMETER INTO THE PREPERITONEAL LOCATION". ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA AND UNDERWENT RECURRENT INCARCERATED INCISIONAL HERNIA REPAIR. PER OPERATIVE NOTES "THE HERNIA WAS IDENTIFIED THEN LYSED ADHESIONS ON THE INTRAPERITONEAL AREA TO GAIN COMPLETE ACCESS. INFERIORLY, I COULD PALPATE THE PREVIOUS MESH (DEVICE #1) REPAIR. THIS APPEARED TO RECOVER JUST SUPERIOR TO THE MESH. I THEREFORE CLEARED OUT AN AREA AND TOOK A PIECE OF MESH 8 CM CIRCLE VENTRALEX ST (DEVICE #2) TYPE. THIS WAS PLACED IN THE INTRAPERITONEAL SPACE, ORIENTED APPROPRIATELY." ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, INTRAABDOMINAL ADHESIONS, UNDERWENT LAPAROSCOPIC RECURRENT VENTRAL INCISIONAL HERNIA REPAIR. PER OPERATIVE NOTES "UPPER MIDLINE ADHESION

  Patient problems: Adhesion(s); Hernia; Necrosis

  MAUDE report 16113899 ↗
• InjuryJul 19, 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 TWO UNSPECIFIED BARD/DAVOL COMPOSITE MESHES (COMPOSIX MESH) ON (B)(6) 2012 AND (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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 15050748 ↗
• InjuryJun 17, 2022Defective 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 MESH (BARD FLAT MESH), BARD/DAVOL VENTRALEX AND COMPOSIX L/P, CIRCLE ON (B)(6) 2011 AND/OR (B)(6) 2012 AND/OR (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR ¿PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 14726885 ↗
• InjuryMar 17, 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 COMPOSIX L/P ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX L/P. 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: Abdominal Pain; Adhesion(s); Insufficient Information

  MAUDE report 13796888 ↗
• InjuryJan 6, 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 COMPOSIX L/P ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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: Abdominal Pain; Hernia; Insufficient Information; Pain; Seroma

  MAUDE report 13175374 ↗
• InjuryNov 1, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL COMPOSIX L/P. IT IS ALLEGED THAT ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH THE PRODUCT IN THE COURSE OF AN INCISIONAL HERNIA REPAIR SURGERY. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT HAS SUFFERED THE DEVELOPMENT OF CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, HERNIA RECURRENCE AND FURTHER REPARATIVE SURGERY WILL BE REQUIRED. IT IS ALSO ALLEGED THAT THE PATIENT HAS CONTINUED TO SUFFER FROM CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, 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. IT IS ALLEGED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUFFERING, INCLUDING CHRONIC PAIN. THE PATIENT HAS BEEN TREATED WITH A COURSE OF HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS. ATTORNEY ALLEGES THAT THE PATIENT WILL REQUIRE FURTHER INVASIVE REPAIR SURGERY, PHYSIOTHERAPY, REHA

  Patient problems: Hernia; Obstruction/Occlusion; Pain

  MAUDE report 12733580 ↗
• InjuryMay 14, 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 COMPOSIX L/P ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 11824111 ↗
• InjuryApr 27, 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 COMPOSIX L/P ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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

  MAUDE report 11733872 ↗
• InjuryApr 6, 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 COMPOSIX L/P ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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 11618639 ↗
• InjuryOct 21, 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 L/P ON (B)(6) 2009 AND (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALSO ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Hernia; Injury

  MAUDE report 10711313 ↗
• InjuryOct 21, 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 TWO UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2009 AND (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALSO ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Hernia; Injury

  MAUDE report 10711312 ↗
• InjurySep 8, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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: Abdominal Pain; Hernia; Injury

  MAUDE report 10500597 ↗
• InjuryJun 2, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX. 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); Injury; Pain

  MAUDE report 10108087 ↗
• InjuryMay 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 COMPOSIX ON (B)(6) 2009. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX. 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: Abdominal Pain; Adhesion(s); Injury

  MAUDE report 10068563 ↗