COMPOSIX 0123680Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00801741031199), received between Sep 5, 2017 and Jun 18, 2026 — classified as 92 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 93 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Material Deformation; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL ABDOMINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESHES (DEVICE 1, 2). PER OP NOTES, "A LARGE HERNIA SAC WAS NOTED FASCIAL RENT IN MIDLINE. TWO COMPOSIX MESHES WERE USED ON EACH SIDE OF DEFECT DUE TO LARGE RENT. THE FIRST COMPOSIX E/X MESH (DEVICE 1) WAS PLACED AS SUBLAY ON LEFT SIDE OF DEFECT AND ANOTHER COMPOSIX E/X MESH (DEVICE 2) WAS PLACED ON RIGHT SIDE OF DEFECT USING SUTURES." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OP NOTES, "THE ADHESIONS WERE FREED UP. THE HERNIA SAC AND CONTENTS WERE REMOVED. THE DEFECT WAS NOTED. THE PREVIOUSLY PLACED MESH (DEVICE 1, 2) HAD COLLAPSED AND AVULSED INTO SOME OF HERNIA SAC, COLON, LIVER. A MESH WAS PLACED TO OVERLAP THE HERNIA DEFECT INTO ABDOMINAL CAVITY USING TACKS." NOTE: THE MESH IMPLANTED IN THIS PROCEDURE WILL BE CONSIDERED AS UNKNOWN).

  Patient problems: Abscess; Adhesion(s); Hernia

  MAUDE report 25551991 ↗
• InjuryAug 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2002 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF UNKNOWN MESH. (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). (B)(6) 2003 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO COMPOSIX E/X (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿DENSE SCAR TISSUE WAS NOTED. THREE LARGE INCISIONAL HERNIAS WITH ENCASED BOWEL WERE NOTED AND DISSECTED. ADHESIONS WERE LYSED. TWO SEPARATE MESHES (DEVICE 1 AND 2) WAS PLACED COVERING THE ENTIRE DEFECT AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA AND ENTEROCUTANEOUS FISTULA AND INFECTED MESH (DEVICE 1 AND 2) THEREBY UNDERWENT REMOVAL OF PREVIOUSLY PLACED MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿INTRAABDOMINAL ADHESIONS OF OMENTUM, SMALL BOWEL, COLON AND HARD CENTRAL FISTULA CLUSTER WERE DISSECTED. THE INFECTED MESHES (DEVICE 1 AND 2) WERE REMOVED AND LOWER ABDOMINAL HERNIA SAC WAS DISSECTED FREE OF ITS WALL. THICK SCAR TISSUE AND RECURRENT VENTRAL INCISIONAL HERNIA WAS CLOSED WITH SUTURES.¿

  Patient problems: Fistula; Hernia; Unspecified Infection

  MAUDE report 22903002 ↗
• InjuryJul 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007: PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC WAS IDENTIFIED, THE HERNIA HERNIATED OMENTUM WAS DISSECTED. THE BRIDGE BETWEEN TWO HERNIAS WERE INCISED. A VENTRALEX MESH (DEVICE #1) WAS PLACED AND SUTURED" (B)(6) 2009: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC WAS IDENTIFIED AND EXCISED. THE OMENTUM WAS ADHERENT TO THE MASS WAS REDUCED. THE FOLDED MESH (DEVICE #1) WAS REMOVED. THE SMALL DEFECT INFERIOR TO THE RECURRENT HERNIA WAS REPAIRED USING SUTURES." (B)(6) 2009: PATIENT WAS DIAGNOSED WITH COMPLEX RECURRENT INCISIONAL HERNIA X2 AND LARGE ABDOMINAL WALL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #2). PER OPERATIVE NOTES, "COMPLEX LARGE ABDOMINAL WALL HERNIA AT THE SITE OF UMBILICUS WAS NOTED, ANOTHER ONE INFERIOR TO THIS. A COMPOSIX E/X MESH (DEVICE #2) WAS PLACED AND TACKED." (B)(6) 2011: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE

  Patient problems: Hernia

  MAUDE report 22370502 ↗
• MalfunctionJun 30, 2022Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE SURGEON IMPLANTED A BARD/DAVOL COMPOSIX E/X MESH WHICH HAD EXPIRED ON (B)(6) 2022 IN THE PATIENT. AS REPORTED, THE MESH WAS REMOVED ONCE NOTICED BEFORE CLOSING THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER IMPLANT WITH A VALID EXPIRATION DATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876548 ↗
• InjuryJun 24, 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 E/X MESH ON (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX E/X MESH. 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: Abscess; Adhesion(s); Fistula; Insufficient Information; Unspecified Infection

  MAUDE report 14799737 ↗
• InjuryJun 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 E/X ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2020. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Bowel Perforation; Erosion; Hernia; Insufficient Information; Pain

  MAUDE report 14604216 ↗
• InjuryMay 26, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  Attorney alleges that the patient underwent surgery for implant of an unspecified Bard/Davol Composix E/X on (b)(6) 2007. As reported, the patient is making a claim for an adverse patient outcome against the Composix E/X. Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient¿. It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2007 - Patient was diagnosed with recurrent incarcerated incisional ventral hernia and umbilical hernia thereby underwent laparoscopic repair with implant of Composix E/X Mesh. Per op notes, ¿Adhesions were identified at the omentum to the lower midline. An umbilical hernia was identified. The upper abdominal hernia was behind the falx, the falx was divided and was taken down. the incarcerated recurrent incisional ventral hernia was identified. A Composix E/X Mesh was placed into the abdominal cavity and tacked to the anterior abdominal wall using staplers.¿ (b)(6) 2020- Patient was diagnosed with ASIA syn

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

  MAUDE report 14515098 ↗
• InjuryMay 24, 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 E/X ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. 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; Obstruction/Occlusion; Pain

  MAUDE report 14490320 ↗
• InjuryMar 29, 2022Defective Device; 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 E/X ON (B)(6) 2004. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. 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 13938919 ↗
• InjuryJul 4, 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 TWO UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2003 AND (B)(6) 2004 AND A COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2005. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. 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); Fistula; Hernia; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 12114200 ↗
• InjuryJul 4, 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 TWO UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2003 AND (B)(6) 2004 AND A COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2005. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. 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); Fistula; Hernia; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 12114197 ↗
• InjuryApr 28, 2021Defective 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 E/X AND MARLEX (BARD FLAT MESH). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X WHICH WAS IMPLANTED ON (B)(6) 2008. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH. PER OPERATIVE NOTES, ¿A LARGE HERNIA SAC WAS IDENTIFIED AND OPENED. A SIGNIFICANT AMOUNT OF BOWEL STUCK IN SAC WAS REDUCED. A COMPOSIX E/X MESH WAS PLACED AND SUTURED. (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INTRA-ABDOMINAL HEMATOMA, SEROMA AND ABDOMINAL PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EVACUATION OF HEMATOMA. PER OPERATIVE NOTES, ¿THE ADHESIONS OF ANTERIOR ABDOMINAL WALL AND OMENTUM WERE TAKEN DOWN. A LARGE AMOUNT OF HEMATOMA WAS IDENTIFIED AND EVACUATED USING SUCTION DEVICE. THE SEROMA WAS DRAINED AND SUTURED. (B)(6)

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

  MAUDE report 11736977 ↗
• InjuryFeb 25, 2021Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT, ON OR ABOUT (B)(6) 2011, THE PATIENT UNDERWENT REPAIR OF A LOWER MIDLINE HERNIA AND WAS IMPLANTED WITH COMPOSIX EX MESH. ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT REVISION OF THE COMPOSIX E/X AND A NON-BARD/DAVOL MESH WAS IMPLANTED. ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT REVISION OF THE COMPOSIX E/X AND NON BARD/DAVOL MESH AND THEN WAS IMPLANTED WITH 6 X 6 IN. MARLEX MESH (BARD FLAT MESH). ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT REMOVAL OF COMPOSIX E/X, BARD MARLEX MESH (BARD FLAT MESH) AND NON BARD/DAVOL MESH. IT IS ALLEGED THAT THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE SEVERE AND CHRONIC PAIN, INFLAMMATION, EVENTRATION OF THE MESH, PELVIC MASS, NECROSIS, SCARRING, ADHESIONS TO SMALL INTESTINE AND BOWEL, AND SURGERY TO REMOVE THE MESHES. 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: Adhesion(s); Disability; Hernia

  MAUDE report 11381205 ↗
• InjuryFeb 15, 2021Defective 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) 2013. 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: Abdominal Pain; Adhesion(s); Injury; Unspecified Infection

  MAUDE report 11326707 ↗
• InjuryFeb 3, 2021Defective 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 E/X ON (B)(6) 2005. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. 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); Disability; Injury; Pain; Scar Tissue

  MAUDE report 11272236 ↗
• InjuryNov 5, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A COMPOSIX E/X ELLIPTICAL MESH IN THE THORACIC CAVITY FOR CHEST WALL RECONSTRUCTION. IT IS ALLEGED THAT THE PATIENT DEVELOPED A POST-OP ASEPTIC INFLAMMATORY REACTION ON (B)(6) 2020; AN ALLERGIC REACTION WAS ALSO ONE OF THE POSSIBILITIES.

  Patient problems: Inflammation; Reaction

  MAUDE report 10790422 ↗
• InjurySep 28, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2004. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. 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; Injury; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 10591715 ↗
• InjuryAug 18, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2007, THE PATIENT WAS IMPLANTED WITH BARD COMPOSIX E/X MESH TO REPAIR A HERNIA. IT IS ALLEGED THAT THE DEFECTIVE MESH DEVICE FAILED, CAUSING THE PATIENT TO EXPERIENCE SEVERE PAIN AND SUFFERING, AND NECESSITATING A MESH REVISION SURGERY ON (B)(6) 2008. THE PATIENT SUFFERED SEVERE COMPLICATIONS FOLLOWING SURGERIES INCLUDING ABDOMINAL PAIN, GASTROINTESTINAL MALFUNCTION, GROTESQUE SWELLING, AND HERNIA RECURRENCE. THE IMPLANTATIONS AND FAILURES OF THE BARD MESH DEVICES HAVE HAD A DEVASTATING IMPACT ON THE PATIENT, LEAVING WITH PERMANENT INJURIES AND IMPAIRMENTS, INCLUDING SCARRING, DISFIGUREMENT, CHRONIC PAIN, AND SUCH FURTHER AND OTHER INJURIES. IT IS ALSO ALLEGED THAT THE PATIENT ALSO EXPERIENCED PAIN, SUFFERING, LOSS OF ENJOYMENT OF LIFE, PERMANENT PHYSICAL DISABILITY, LOSS OF PHYSICAL, MENTAL AND EMOTIONAL HEALTH. THE PATIENT CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT AND ALLEGES FOR FURTHER MEDICAL CARE IN THE FORESEEABLE FUTURE. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Deformity/ Disfigurement; Disability; Hernia

  MAUDE report 10423085 ↗
• InjuryJul 7, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2002. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. 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; Disability; Injury; Pain

  MAUDE report 10239929 ↗
• InjuryJun 13, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL 3DMAX AND COMPOSIX E/X. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X WHICH WAS IMPLANTED ON (B)(6) 2009. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL IN LOWER QUADRANTS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF ONE 3DMAX MESH (DEVICE #1) AND TWO SYNTHETIC MESH. PER OPERATIVE NOTES, ¿ IN LEFT LOWER QUADRANT, HERNIA WAS NOTED AROUND THE PREVIOUSLY PLACED MESH. THE HERNIA WAS REDUCED AND 3DMAX MESH (DEVICE #1) WAS PLACED IN LEFT SIDE AND SUTURED. THE RIGHT LOWER QUADRANT HERNIA WAS REDUCED AND TWO SYNTHETIC MESHES WERE PLACED AND SUTURED.¿ (NOTE: THE PREVIOUSLY PLACED MESH WAS UNKNOWN) (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA WITH PARTIAL BOWEL O

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

  MAUDE report 10151304 ↗
• InjuryJun 3, 2020Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. 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 10114387 ↗
• InjuryMay 15, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2005 AND TWO SEPRAMESH IP COMPOSITE ON (B)(6) 2009 AND (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2009. ATTORNEY ALSO ALLEGES GENERAL ALLEGATIONS FOR ¿PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 10060815 ↗
• InjuryMay 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT OF A COMPOSIX E/X MESH IN 2005 AND IS CURRENTLY HOSPITALIZED. AS REPORTED, THE DOCTOR INQUIRED REGARDING THE MATERIAL CONTENT OF THE SURGICAL MESH AND WANTED TO KNOW WHETHER IF IT WAS "GORE-TEX".

  Patient problems: Injury

  MAUDE report 10052888 ↗
• InjuryApr 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 TWO UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2004 AND A VENTRALEX ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2009. 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; Unspecified Infection

  MAUDE report 10009312 ↗
• InjuryApr 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 TWO UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2004 AND A VENTRALEX ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2009. 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; Unspecified Infection

  MAUDE report 10009263 ↗