GORE DUALMESH PLUS BIOMATERIAL 1DLMCP05Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00733132601127), received between Jun 27, 2018 and Aug 4, 2023 — classified as 22 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT PROCEDURE: REPAIR OF INCARCERATED INCISIONAL HERNIA WITH MESH (GORE-TEX DUAL MESH) WITH INTERMEDIATE CLOSURE (10 CM).[IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP05/01284551, 8CM X 12CM X 1MM THICK. IMPLANT DATE: (B)(6) 2003. EXPLANT PROCEDURE: EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, EXCISION OF AN OLD MESH, VENTRAL HERNIA REPAIR WITH A 13 X 13 CM UNDERLAY OF BIOLOGICAL MESH. EXPLANT DATE: (B)(6) 2014. IMPLANT #1: (B)(6) 2003. IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: BOWEL OBSTRUCTION, RECURRRENCE, LYSIS OF ADHESIONS, EXCISION OF OLD MESH, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17461576 ↗
• InjuryJul 12, 2022Output Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY TWO GORE-TEX® SOFT TISSUE PATCHES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED AND A THIRD GORE DEVICE WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENT VENTRAL HERNIA DUE TO MESH FAILURE; DENSELY ADHERED TO BOWEL LOOPS; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 14988563 ↗
• InjuryJul 12, 2022Output Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY TWO GORE-TEX® SOFT TISSUE PATCHES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED AND A THIRD GORE DEVICE WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENT VENTRAL HERNIA DUE TO MESH FAILURE; DENSELY ADHERED TO BOWEL LOOPS; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 14988520 ↗
• InjuryJul 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12110249 ↗
• InjuryMar 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC OPEN VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2005 AND (B)(6) 2006 WHEREBY GORE® DUALMESH® BIOMATERIAL AND GORE® DUALMESH® PLUS BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006, (B)(6) 2008, AND (B)(6) 2008, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: DENSE ADHESIONS, MULTIPLE BOWEL OBSTRUCTION, RECURRENCES, MESH INFECTION, ABSCESS, MESH REMOVAL, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 11586171 ↗
• InjuryMar 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6), 2005 WHEREBY A GORE DUALMESH PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SMALL BOWEL OBSTRUCTION; SMALL BOWEL RESECTION; REMOVAL OF MESH; ADHESIONS; PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11584571 ↗
• InjuryMar 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC EPIGASTRIC HERNIA REPAIR ON (B)(6), 2004 WHEREBY A GORE DUALMESH PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2004, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN, HERNIA RECURRENCE DUE TO FAILURE OF MESH. FAILURE MODE IS MIGRATION OF MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; Unspecified Infection

  MAUDE report 11582924 ↗
• InjuryNov 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2004, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF GORE MESH BECAUSE IT HAD SEPARATED FROM THE EDGES, GORE MESH EDGES WERE EXPOSED, ADHESIONS, RECURRENT UMBILICAL HERNIA REPAIRED WITH PLACEMENT OF NEW MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 10864155 ↗
• InjurySep 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL UMBILICAL, INCISIONAL EPIGASTRIC, HERNIA REPAIR ON (B)(6) 2010, WHEREBY TWO GORE® DUALMESH® BIOMATERIAL'S WERE IMPLANTED. THE PATIENT ALSO UNDERWENT OPEN INCISIONAL RIGHT FLANK, AND INCISIONAL VENTRAL HERNIA REPAIR ON (B)(6) 2011, WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL'S WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, (B)(6) 2014, (B)(6) 2015, (B)(6) 2016 AND (B)(6) 2018 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF GORE MESH DUE TO IT WAS FOUND BRIDGING AND PULLED AWAY FROM EDGES, BOWEL OBSTRUCTION, MULTIPLE SWISS-CHEESE DEFECT, DENSE ADHESIONS, INCARCERATED RECURRENT VENTRAL HERNIA REPAIRED WITH PLACEMENT OF NEW MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions; No Code Available; Obstruction/Occlusion

  MAUDE report 10497313 ↗
• InjurySep 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, INFECTED MESH, REVISION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 10483449 ↗
• InjuryAug 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL/INCISIONAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT APPROXIMATELY (B)(6) 2009, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE(S) WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: FAILED MESH, HERNIA RECURRENCE, MESH ROLLED UP, PAIN, FISTULA, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Fistula; Hernia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10451826 ↗
• InjuryNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN AND SUFFERING; ADHESIONS; ABDOMINAL WALL REPAIR RESULTING IN REVISION OF THE PLACED MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); No Clinical Signs, Symptoms or Conditions; No Code Available; Pain

  MAUDE report 9363261 ↗
• InjuryNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL AND UMBILICAL HERNIA REPAIR ON (B)(6) 2006 AND ON (B)(6) 2008 WHEREBY MULTIPLE GORE® DUALMESH® PLUS BIOMATERIALS WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2008, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE(S) WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTED MESH REQUIRING REMOVAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 9362884 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, MESH REMOVAL FOR INFECTED MESH, (B)(6) 2016 - FISTULA TAKEDOWN, REMOVAL OF APPENDIX, MESH REMOVAL, AND MESH REPAIR. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: "FAILED MESH, EXPLANTATION, RECURRENCE, ENTRAPMENT OF BOWEL, ADHESIONS, BOWEL PERFORATION, AND FISTULA." ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Fistula; Hernia; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 9278587 ↗
• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON (B)(6) 2007, WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH PALPATED, MESH PULLED AWAY FROM LEFT SIDE THUS NEEDING REVISION SURGERY ON 12/09/2015. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 9186162 ↗
• InjurySep 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2008, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABDOMINAL PAIN, INFECTED MESH, MESH REMOVAL, AND ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abdominal Pain; Unspecified Infection

  MAUDE report 8957182 ↗
• InjuryAug 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, INFECTED MESH, REVISION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 8928518 ↗
• InjuryApr 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2009, WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, OPEN DRAINING WOUND, ABSCESS, FIBROSIS, CICATRIX OF THE SKIN AND ABDOMINAL MESH MATERIAL, INFLAMMATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Inflammation; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 8567233 ↗
• InjuryJan 22, 2019Contamination; Insufficient Device Problem Information; Contamination; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN, ADDITIONAL SURGERY, MESH REMOVAL, INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8266814 ↗
• InjuryDec 14, 2018No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE DUALMESH®PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2015 WHEREBY A GORE DUALMESH®PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, LYSIS OF ADHESIONS, RECURRENT INCARCERATED INCISIONAL HERNIA REPAIR. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Hernia; Not Applicable

  MAUDE report 8163980 ↗
• InjuryNov 29, 2018No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2007, WHEREBY A GORE DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2012, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY EXPLANT OF THE GORE DEVICE WAS PERFORMED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, MESH FAILURE, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8116924 ↗
• InjuryJun 27, 2018No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABDOMINAL PAIN, DYSPHAGIA, NAUSEA AND VOMITING, CHANGE IN BOWEL HABITS, HERNIA RECURRENCE, DENSE ADHESIONS, AND MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION AND MEDICAL RECORDS HAVE BEEN REQUESTED.

  Patient problems: Dysphagia/ Odynophagia; Nausea; Not Applicable; Pain

  MAUDE report 7641085 ↗