ETHICON PHYSIOMESH PHY2025VRecalls & reported problems
Johnson & Johnson International Inc. · Physiomesh Flexible Composite Mesh · Class 2 · Implant
Quick summary
This Ethicon Physiomesh surgical mesh is implanted to reinforce hernia repairs. The 30 reports mostly describe patients who went on to have the mesh removed or revised, along with severe pain, adhesions (scar tissue binding organs together), inflammation, infection, and bowel obstruction. All 30 involve injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705031132344), received between Feb 12, 2020 and Jul 18, 2025 — classified as 30 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem30
Patient problems
- Pain18
- Adhesion(s)12
- Chills10
- Diarrhea10
- Inflammation10
- Nausea10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Hernia9
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED DUE ABDOMINAL AORTIC ANEURYSM AND BILATERAL ILIAC ARTERY ANEURYSMS. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY LAST ON (B)(6) 2008 AND MESH WAS IMPLANTED AND REMOVAL SURGERY ON (B)(6) 2011. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE.
Patient problems: Insufficient Information
MAUDE report 22545375 ↗InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT RECURRENT VENTRAL HERNIA ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2009 AND TWO (2) MESHES WERE IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA AND MESH WAS IMPLANTED ON (B)(6) 2010. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21991451 ↗InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. IT WAS REPORTED PATIENT EXPERIENCED SEVERE PAIN, SEROMA, INFECTION, FISTULA, DENSE ADHESIONS AND SCAR TISSUE, AND CHRONIC OPEN DRAINING WOUND. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Fistula; Fluid Discharge; Pain; Scar Tissue; Seroma; Unspecified Infection
MAUDE report 21511822 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, AND A SMALL BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Chills; Diarrhea; Inflammation; Nausea; Obstruction/Occlusion; Pain
MAUDE report 21399944 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, AND A SMALL BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Chills; Diarrhea; Inflammation; Nausea; Obstruction/Occlusion; Pain
MAUDE report 21398012 ↗InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REMOVAL OF PREVIOUS MESH ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD RECURRENT HERNIA REPAIR ON (B)(6)2012 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21089417 ↗InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THE LARGE VENTRAL HERNIA WITH INCARCERATE OMENTUM. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Abdominal Pain
MAUDE report 20735619 ↗InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT UNDERWENT REVISION SURGERY ON (B)(6) 2023 DUE TO HERNIA RECURRENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hernia
MAUDE report 20649999 ↗InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, AND A SMALL BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: Chills; Diarrhea; Inflammation; Nausea; Obstruction/Occlusion; Pain
MAUDE report 20607810 ↗InjurySep 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE, AND EXTREME WEIGHT LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes
MAUDE report 20118311 ↗InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY LAST (B)(6) 2009 AND (B)(6) 2013 AND PROCEED WAS IMPLANTED AND HAD ANOTHER SURGERY LAST (B)(6) 2009 AND PHYSIOMESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s)
MAUDE report 20076183 ↗InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA PROCEDURE ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021 DUE TO RECURRENT INCISIONAL HERNIA. IT WAS REPORTED THAT PATIENT EXPERIENCED ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Hernia
MAUDE report 17718717 ↗InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT DIED.
Patient problems: Insufficient Information
MAUDE report 16403237 ↗InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021 DURING WHICH THE SURGEON NOTED THE MESH WAS NOTED TO BE DENSELY ADHERENT TO THE BOWEL. THE ADHESIONS WERE SO SEVERE THAT PORTIONS OF THE BOWEL HAD TO BE REMOVED ALONG WITH THE MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, EXTENSIVE ADHESIONS, INFECTION, SMALL BOWEL RESECTION, ABDOMINAL WALL ABSCESS, CHILLS, INFLAMMATION AND LOSS OF APPETITE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Abscess; Adhesion(s); Chills; Decreased Appetite; Inflammation; Pain; Unspecified Infection
MAUDE report 16230860 ↗InjuryNov 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENTS.
Patient problems: Insufficient Information
MAUDE report 15859733 ↗InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Abdominal Pain; Adhesion(s); Hernia; Insufficient Information
MAUDE report 15757167 ↗InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Discomfort; Hernia; Insufficient Information; Pain
MAUDE report 15750144 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THE PREVIOUSLY PLACED MESH WAS ASSOCIATED WITH OMENTAL ADHESIONS AND SCAR TISSUE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021 DURING WHICH THE SURGEON NOTED UPON ENTRY TO THE ABDOMEN, IT WAS NOTED THAT HE HAD DENSE BOWEL AND OMENTAL ADHESIONS STUCK TO THE MESH. APPROXIMATELY 1 FOOT TO 18 INCHES OF HIS BOWEL HAD TO BE REMOVED DUE TO ADHESIONS AND OBSTRUCTION. HE THEN REMOVED THE MESHES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN, SCARRING, ANXIETY, MENTAL ANGUISH AND STRESS. THE PATIENT HAD HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2003 WHICH IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Obstruction/Occlusion; Pain; Scar Tissue
MAUDE report 15344060 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Obstruction/Occlusion; Pain
MAUDE report 15325257 ↗InjuryAug 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Pain
MAUDE report 15222922 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED A DEFECT WAS NOTED IN THE INFERIOR/LATERAL ASPECT WHERE THE MESH WAS NOT ADHERED TO THE ABDOMINAL WALL. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DURING WHICH THE SURGEON NOTED THE MESH WAS PALPATED INFERIORLY AND SEEMED TO HAVE PULLED AWAY IN THIS AREA. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED WE DID ENCOUNTER A COUPLE DIFFERENT LAYERS OF MESH IN THIS AREA. IT WAS INFERIORLY AGAIN WHERE THIS APPEARED TO HAVE PULLED FREE. ANTERIORLY, THE MESH WAS IDENTIFIED AS A THICKENED VERY FIBROTIC MASS. EVENTUALLY DURING THE PROCEDURE, WE ENDED UP REMOVING PRETTY MUCH ALL OF THIS IN ITS ENTIRETY. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016 DURING WHICH THE SURGEON NOTED THE MESH WAS IDENTIFIED IN THE LOWER ABDOMEN AND THERE WAS BOWEL ADHERENT TO THE MES
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes
MAUDE report 13866438 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED A DEFECT WAS NOTED IN THE INFERIOR/LATERAL ASPECT WHERE THE MESH WAS NOT ADHERED TO THE ABDOMINAL WALL. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DURING WHICH THE SURGEON NOTED THE MESH WAS PALPATED INFERIORLY AND SEEMED TO HAVE PULLED AWAY IN THIS AREA. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED WE DID ENCOUNTER A COUPLE DIFFERENT LAYERS OF MESH IN THIS AREA. IT WAS INFERIORLY AGAIN WHERE THIS APPEARED TO HAVE PULLED FREE. ANTERIORLY, THE MESH WAS IDENTIFIED AS A THICKENED VERY FIBROTIC MASS. EVENTUALLY DURING THE PROCEDURE, WE ENDED UP REMOVING PRETTY MUCH ALL OF THIS IN ITS ENTIRETY. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016 DURING WHICH THE SURGEON NOTED THE MESH WAS IDENTIFIED IN THE LOWER ABDOMEN AND THERE WAS BOWEL ADHERENT TO THE MES
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Decreased Appetite; Diarrhea; Fibrosis; Hernia; Inflammation; Nausea; Pain; Weight Changes
MAUDE report 13866420 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED A DEFECT WAS NOTED IN THE INFERIOR/LATERAL ASPECT WHERE THE MESH WAS NOT ADHERED TO THE ABDOMINAL WALL. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DURING WHICH THE SURGEON NOTED THE MESH WAS PALPATED INFERIORLY AND SEEMED TO HAVE PULLED AWAY IN THIS AREA. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED WE DID ENCOUNTER A COUPLE DIFFERENT LAYERS OF MESH IN THIS AREA. IT WAS INFERIORLY AGAIN WHERE THIS APPEARED TO HAVE PULLED FREE. ANTERIORLY, THE MESH WAS IDENTIFIED AS A THICKENED VERY FIBROTIC MASS. EVENTUALLY DURING THE PROCEDURE, WE ENDED UP REMOVING PRETTY MUCH ALL OF THIS IN ITS ENTIRETY. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016 DURING WHICH THE SURGEON NOTED THE MESH WAS IDENTIFIED IN THE LOWER ABDOMEN AND THERE WAS BOWEL ADHERENT TO THE MES
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Decreased Appetite; Diarrhea; Foreign Body In Patient; Inflammation; Nausea; Pain; Weight Changes
MAUDE report 13866366 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED A DEFECT WAS NOTED IN THE INFERIOR/LATERAL ASPECT WHERE THE MESH WAS NOT ADHERED TO THE ABDOMINAL WALL. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DURING WHICH THE SURGEON NOTED THE MESH WAS PALPATED INFERIORLY AND SEEMED TO HAVE PULLED AWAY IN THIS AREA. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED WE DID ENCOUNTER A COUPLE DIFFERENT LAYERS OF MESH IN THIS AREA. IT WAS INFERIORLY AGAIN WHERE THIS APPEARED TO HAVE PULLED FREE. ANTERIORLY, THE MESH WAS IDENTIFIED AS A THICKENED VERY FIBROTIC MASS. EVENTUALLY DURING THE PROCEDURE, WE ENDED UP REMOVING PRETTY MUCH ALL OF THIS IN ITS ENTIRETY. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016 DURING WHICH THE SURGEON NOTED THE MESH WAS IDENTIFIED IN THE LOWER ABDOMEN AND THERE WAS BOWEL ADHERENT TO THE MES
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes
MAUDE report 13866270 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED A DEFECT WAS NOTED IN THE INFERIOR/LATERAL ASPECT WHERE THE MESH WAS NOT ADHERED TO THE ABDOMINAL WALL. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DURING WHICH THE SURGEON NOTED THE MESH WAS PALPATED INFERIORLY AND SEEMED TO HAVE PULLED AWAY IN THIS AREA. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED WE DID ENCOUNTER A COUPLE DIFFERENT LAYERS OF MESH IN THIS AREA. IT WAS INFERIORLY AGAIN WHERE THIS APPEARED TO HAVE PULLED FREE. ANTERIORLY, THE MESH WAS IDENTIFIED AS A THICKENED VERY FIBROTIC MASS. EVENTUALLY DURING THE PROCEDURE, WE ENDED UP REMOVING PRETTY MUCH ALL OF THIS IN ITS ENTIRETY. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016 DURING WHICH THE SURGEON NOTED THE MESH WAS IDENTIFIED IN THE LOWER ABDOMEN AND THERE WAS BOWEL ADHERENT TO THE MES
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Decreased Appetite; Diarrhea; Hernia; Inflammation; Nausea; Pain; Weight Changes
MAUDE report 13866105 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.