ETHICON PHYSIOMESH PHY1520VRecalls & reported problems
Johnson & Johnson International Inc. · Physiomesh Flexible Composite Mesh · Class 2 · Implant
Quick summary
This Ethicon Physiomesh surgical mesh is implanted to repair hernias. Most of the 49 reports describe pain, inflammation, adhesions (scar tissue sticking to organs), nausea, and recurring hernias, sometimes requiring surgery to remove infected mesh. All 49 involve injuries, with no deaths. No recalls name this device. Reports dropped sharply, from 9 in the prior 12 months to none in the last 12 months.
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
- 49
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705031132337), received between Dec 11, 2017 and Jul 14, 2025 — classified as 49 injuries.
The most frequently reported specific device problem is “Contamination” (1 report).
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
- Appropriate Device Problem Term/Code Not Available26
- Adverse Event Without Identified Device or Use Problem24
- Contamination1
Patient problems
- Pain24
- Not Applicable17
- Inflammation15
- Adhesion(s)14
- Hernia13
- Nausea13
- Injury10
- Unspecified Infection8
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 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 REPAIR OF INCISIONAL HERNIA AND A MESH WAS IMPLANTED ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22493600 ↗InjuryApr 24, 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 EXPLANTATION OF MESH AND REPAIR OF RECURRENT VENTRAL HERNIA ON (B)(6) 2014 AND A MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED ¿ADHESIONS IN THE ANTERIOR MIDLINE, THERE WAS A LARGE, ENCAPSULATED HERNIA SAC AND PORTION OF CAPSULE INVOLVING A PIECE OF MESH WHICH WAS PULLED AWAY FROM THE OPPOSITE SIDE. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY LAST ON (B)(6) 2014 AND A MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21906035 ↗InjuryMar 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 INCISIONAL HERNIA AND MESH WAS IMPLANTED ON (B)(6) 2011. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD UNDERWENT REPAIR INCISIONAL HERNIA AND MESH WAS IMPLANTED ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21556579 ↗InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21309215 ↗InjuryJan 28, 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) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023 DURING WHICH THE SURGEON NOTED MULTIPLE ADHESIONS AND INFECTED MESH. THE SURGEON LYSED ALL OF THE ADHESIONS AND REMOVED THE INFECTED MESH. IT WAS REPORTED PATIENT EXPERIENCED SEVERE PAIN, ADHESIONS AND INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Pain; Unspecified Infection
MAUDE report 21250494 ↗InjuryDec 11, 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 ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR AND REMOVAL SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s)
MAUDE report 20904096 ↗InjuryDec 9, 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 (B)(6) 2015 AND MESH IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20875661 ↗InjuryDec 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 ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20825091 ↗InjuryNov 1, 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 LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT DEVELOPED INCARCERATED SMALL BOWEL HERNIA AND EXPERIENCED ABDOMINAL PAIN, SEVERE NAUSEA, AND VOMITING. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Abdominal Pain; Hernia; Nausea; Vomiting
MAUDE report 20585174 ↗InjuryAug 9, 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 HAD 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 MESH AND THE PRO-TAK COILS. A LYSIS OF ADHESIONS WAS DONE CIRCUMFERENTIALLY TO FREE THE BOWEL FROM THE MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR AND REMOVAL OF MESH ON (B)(6) 2016 DUE TO INFECTED MESH AND WITH PROBABLE ENTEROCUTANEOUS FISTULA. THE MESH AND ALL FOREIGN MATERIAL WAS REMOVED FROM THE ABDOMEN. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURG
Patient problems: Fistula; Unspecified Infection
MAUDE report 19956867 ↗InjuryJun 4, 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) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023 DURING WHICH THE SURGEON NOTED THE SUPERIOR PORTION OF THE MESH HAD PULLED AWAY. HE PERFORMED EXTENSIVE LYSIS OF ADHESIONS. IT WAS REPORTED THAT PATIENT EXPERIENCED AN UNKNOWN SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Abscess; Adhesion(s); Chills; Decreased Appetite; Diarrhea; Hernia; Inflammation; Nausea; Pain; Weight Changes
MAUDE report 19464478 ↗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 HAD 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 MESH AND THE PRO-TAK COILS. A LYSIS OF ADHESIONS WAS DONE CIRCUMFERENTIALLY TO FREE THE BOWEL FROM THE MESH. THE MESH AND ALL FOREIGN MATERIAL WAS REMOVED FROM THE ABDOMEN. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD 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 W
Patient problems: Chills; Decreased Appetite; Diarrhea; Fistula; Inflammation; Nausea; Pain; Unspecified Infection; Weight Changes
MAUDE report 13866365 ↗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 HAD 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 MESH AND THE PRO-TAK COILS. A LYSIS OF ADHESIONS WAS DONE CIRCUMFERENTIALLY TO FREE THE BOWEL FROM THE MESH. THE MESH AND ALL FOREIGN MATERIAL WAS REMOVED FROM THE ABDOMEN. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD 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 W
Patient problems: Adhesion(s); Chills; Decreased Appetite; Diarrhea; Fibrosis; Fistula; Foreign Body In Patient; Inflammation; Nausea; Pain; Unspecified Infection; Weight Changes
MAUDE report 13866307 ↗InjurySep 14, 2020Adverse 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) 2019 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Hernia; Injury; Pain
MAUDE report 10528334 ↗InjuryAug 20, 2019Adverse 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 PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND PERMANENT SCARRING FOLLOWING SURGERY. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012. OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Abdominal Pain; Edema; Hernia; Inflammation; No Code Available; Not Applicable; Scarring
MAUDE report 8910930 ↗InjurySep 4, 2018Adverse 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 UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT UNDERWENT EXPLANT SURGERY ON (B)(6) 2017 WHERE THE SURGEON NOTED ¿THAT THE PATCH HAD MIGRATED CEPHALAD AND TO THE RIGHT UPPER QUADRANT, AWAY FROM ITS ORIGINAL POSITION, EXPOSING THE UMBILICAL REGION. THE INFERIOR EDGE OF THE PATCH WAS AT THE SUPERIOR EDGE OF THE UMBILICAL DEFECT.¿ IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, DIARRHEA, INFLAMMATION AND EXTREME WEIGHT LOSS. NO ADDITIONAL INFORMATION IS PROVIDED.
Patient problems: Inflammation; Not Applicable; Pain
MAUDE report 7841814 ↗InjurySep 3, 2018Adverse 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 VENTRAL INCISIONAL AND UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2012 AND TO PIECES OF MESH WERE IMPLANTED. IT WAS REPORTED THE PATIENT UNDERWENT REPAIR SURGERY ON (B)(6) 2013. IT WAS REPORTED THE PATIENT EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Abdominal Pain; Adhesion(s); Not Applicable; Pain; Sweating
MAUDE report 7840778 ↗InjuryAug 8, 2018Adverse 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. IT WAS REPORTED THAT HE EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Injury
MAUDE report 7763763 ↗InjuryAug 6, 2018Adverse 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 EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Injury
MAUDE report 7754781 ↗InjuryAug 2, 2018Adverse 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) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERIES ON (B)(6) 2013 AND (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Not Applicable
MAUDE report 7744220 ↗InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2014 AND THE SURGEON NOTED LARGE VENTRAL HERNIA AND HERNIA SAC AND ¿CARE WAS TAKEN TO DISSECT THE ADHESIONS AND HERNIA SAC FREE.¿ THE SKIN AND SUBCUTANEOUS TISSUE WAS FREED FOR APPROXIMATELY 9 CM IN BOTH DIRECTIONS, LATERALLY. MESH WAS SUTURED INTO PLACE IN 4 QUADRANTS AND ¿THEN IN BETWEEN EACH INITIAL TACKING SUTURE, UNTIL THIS WAS WELL SECURED.¿ ADDITIONAL OVERLAY MESH WAS ALSO TACKED OVER THE PRIMARY AND SYNTHETIC MESH REPAIRS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA WITH MESH AND COMPONENT SEPARATION ON (B)(6) 2014 AND THE SURGEON NOTED ¿THE MESH COULD BE SEEN PULLED OUT AND AWAY FROM ITS INFERIOR POSITION¿ WHICH WAS REMOVED IN ITS ENTIRETY. NO ADDITIONAL INFORMATION IS REPORTED AT THIS TIME.
Patient problems: Adhesion(s); Hernia; Not Applicable
MAUDE report 7687524 ↗InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS FURTHER REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WERE NOTED AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT AGAIN UNDERWENT SURGERY TO REPAIR RECURRENT INCISIONAL HERNIA ON (B)(6) 2012 AND EXTENSIVE ADHESIONS TO THE ANTERIOR ABDOMINAL WALL AND ¿TO THE OLD MESH¿. THE MESH WAS PULLED AWAY FROM THE FASCIA IN THE LEFT LOWER QUADRANT WITH SMALL HERNIA AND ANOTHER MESH WAS IMPLANTED. IT WAS FURTHER REPORTED THE PATIENT UNDERWENT SURGERY ON (B)(6) 2016 TO DEBRIDE AND EXCISE ABDOMINAL WALL TUMOR (SCARS, FOREIGN BODIES AND HERNIA MATERIALS), COMPLEX ABDOMINAL WALL AND HERNIA ADVANCEMENT REPAIR. IT WAS REPORTED THE PATIENT UNDERWENT REMOVAL OF OLD INFECTED MESH ON (B)(6) 2017 AND THEN ADDITIONAL SURGERY ON (B)(6) 2017 TO EXPLORE, DEBRIDE AND REMOVE OLD INFECTED MESH, EXPLANT MESH FROM LIVER, CONTROL OF LIVER LACERATIONS AND BLEEDING, COMPLEX MULTIPLE FLAPS AND ABDOMINAL REPAIR. IT WAS NOTED THE PLASTIC MESH WAS FIRMLY ADHERENT TO THE PREPERITONEAL FAT AND ENDOABDOMINAL FASCIA. IT WAS REPORTED THE MESH HAD EITHER PINFOLDED OR HAD FOLDED ON ITSELF AND CRINKLED, CREATING AN IN
Patient problems: Adhesion(s); Inflammation; Unspecified Infection
MAUDE report 7683061 ↗InjuryJul 3, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT SURGERY TO REPAIR AN INCARCERATED VENTRAL INCISIONAL HERNIA ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF A PORTION OF THE MESH ON (B)(6) 2014 AND THE SURGEON NOTE THE MESH WAS ¿MARKEDLY ATTENUATED WITH SOME RECURRENT HERNIATIONS CENTRALLY WITH MESH FAILURE.¿ IT WAS REPORTED THE PATIENT CONTINUES TO EXPERIENCE SEVERE PAIN, BLOATING, DIARRHEA AND CONSTIPATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hernia; Not Applicable; Pain
MAUDE report 7659972 ↗InjuryJul 2, 2018Contamination
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2010 AND THE MESH WAS IMPLANTED OVER AN AORTOBIFEMORAL BYPASS INCISIONAL HERNIA THAT MEASURED 2.5CM. TWO WEEKS LATER, THE MESH WAS REMOVED ON (B)(6) 2010 AS WELL AS ABDOMINAL MUSCLES, NERVES, AND BELLY BUTTON. IT WAS ALSO REPORTED THAT THERE WAS NO PATHOLOGY REPORT DONE BECAUSE THE ORGANISM WHICH CAUSED OF INFECTION WAS KNOWN. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BOWEL OBSTRUCTION FROM SCAR TISSUE FROM TWO PRIOR SURGERIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Not Applicable; Unspecified Infection
MAUDE report 7657446 ↗InjuryJul 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
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 EXPERIENCED PAIN IN THE GROIN AND UMBILICUS. IT WAS REPORTED THAT HE UNDERWENT RECURRENT RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2015 AND MESH WERE IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Not Applicable; Pain
MAUDE report 7655138 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.