NATURA 411803Recalls & reported problems

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 00768455105977), received between Apr 10, 2019 and Jun 15, 2026 — classified as 161 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (157 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 161 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Malposition of Device

  THE CONSUMER REPORTED THAT SIX UNITS WERE UNUSABLE DUE TO AN OFF-CENTER STARTER HOLE, WHILE FOUR UNITS FROM THE SAME BOX WERE USABLE WITH MINOR DEVIATION. WHEN PROPERLY CENTERED, THE DEVICE ACHIEVED EXPECTED PERFORMANCE (UP TO 5 DAYS WEAR TIME). THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505917 ↗
• MalfunctionJun 15, 2026Malposition of Device

  THE CONSUMER REPORTED THAT SIX UNITS WERE UNUSABLE DUE TO AN OFF-CENTER STARTER HOLE, WHILE FOUR UNITS FROM THE SAME BOX WERE USABLE WITH MINOR DEVIATION. WHEN PROPERLY CENTERED, THE DEVICE ACHIEVED EXPECTED PERFORMANCE (UP TO 5 DAYS WEAR TIME). THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505915 ↗
• MalfunctionJun 15, 2026Malposition of Device

  THE CONSUMER REPORTED THAT SIX UNITS WERE UNUSABLE DUE TO AN OFF-CENTER STARTER HOLE, WHILE FOUR UNITS FROM THE SAME BOX WERE USABLE WITH MINOR DEVIATION. WHEN PROPERLY CENTERED, THE DEVICE ACHIEVED EXPECTED PERFORMANCE (UP TO 5 DAYS WEAR TIME). THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505914 ↗
• MalfunctionJun 15, 2026Malposition of Device

  THE CONSUMER REPORTED THAT SIX UNITS WERE UNUSABLE DUE TO AN OFF-CENTER STARTER HOLE, WHILE FOUR UNITS FROM THE SAME BOX WERE USABLE WITH MINOR DEVIATION. WHEN PROPERLY CENTERED, THE DEVICE ACHIEVED EXPECTED PERFORMANCE (UP TO 5 DAYS WEAR TIME). THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505913 ↗
• MalfunctionJun 15, 2026Malposition of Device

  THE CONSUMER REPORTED THAT SIX UNITS WERE UNUSABLE DUE TO AN OFF-CENTER STARTER HOLE, WHILE FOUR UNITS FROM THE SAME BOX WERE USABLE WITH MINOR DEVIATION. WHEN PROPERLY CENTERED, THE DEVICE ACHIEVED EXPECTED PERFORMANCE (UP TO 5 DAYS WEAR TIME). THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505910 ↗
• MalfunctionJun 15, 2026Malposition of Device

  THE CONSUMER REPORTED THAT SIX UNITS WERE UNUSABLE DUE TO AN OFF-CENTER STARTER HOLE, WHILE FOUR UNITS FROM THE SAME BOX WERE USABLE WITH MINOR DEVIATION. WHEN PROPERLY CENTERED, THE DEVICE ACHIEVED EXPECTED PERFORMANCE (UP TO 5 DAYS WEAR TIME). THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505908 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE CUSTOMER REPORTED THAT THE PRODUCT OPENINGS IN THE BOX WERE OFF-CENTERED. HE STATED THAT ALL TEN WAFERS IN THE BOX WERE AFFECTED AND NOTED THAT THIS BOX HAD BEEN PROVIDED AS A REPLACEMENT FOR THE SAME ISSUE REPORTED IN A PREVIOUS COMPLAINT. THE CUSTOMER INDICATED THAT THE OPENINGS IN ALL WAFERS WERE MISALIGNED, WITH SOME MORE NOTICEABLY OFF-CENTER THAN OTHERS, RENDERING SEVERAL WAFERS COMPLETELY UNUSABLE FOR HIM. HE CONFIRMED THAT HE HAD NOT USED ANY WAFERS FROM THIS BOX. HE FURTHER EXPLAINED THAT WHEN HE HAD PREVIOUSLY USED PRODUCTS WITH THIS ISSUE, HE HAD BEEN UNABLE TO ACHIEVE A PROPER SEAL. HE EMPHASIZED THAT AN EVENLY CENTERED OPENING WAS CRUCIAL FOR HIM DUE TO THE PRESENCE OF A PARASTOMAL HERNIA. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389332 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE CUSTOMER REPORTED THAT THE PRODUCT OPENINGS IN THE BOX WERE OFF-CENTERED. HE STATED THAT ALL TEN WAFERS IN THE BOX WERE AFFECTED AND NOTED THAT THIS BOX HAD BEEN PROVIDED AS A REPLACEMENT FOR THE SAME ISSUE REPORTED IN A PREVIOUS COMPLAINT. THE CUSTOMER INDICATED THAT THE OPENINGS IN ALL WAFERS WERE MISALIGNED, WITH SOME MORE NOTICEABLY OFF-CENTER THAN OTHERS, RENDERING SEVERAL WAFERS COMPLETELY UNUSABLE FOR HIM. HE CONFIRMED THAT HE HAD NOT USED ANY WAFERS FROM THIS BOX. HE FURTHER EXPLAINED THAT WHEN HE HAD PREVIOUSLY USED PRODUCTS WITH THIS ISSUE, HE HAD BEEN UNABLE TO ACHIEVE A PROPER SEAL. HE EMPHASIZED THAT AN EVENLY CENTERED OPENING WAS CRUCIAL FOR HIM DUE TO THE PRESENCE OF A PARASTOMAL HERNIA. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389331 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE CUSTOMER REPORTED THAT THE PRODUCT OPENINGS IN THE BOX WERE OFF-CENTERED. HE STATED THAT ALL TEN WAFERS IN THE BOX WERE AFFECTED AND NOTED THAT THIS BOX HAD BEEN PROVIDED AS A REPLACEMENT FOR THE SAME ISSUE REPORTED IN A PREVIOUS COMPLAINT. THE CUSTOMER INDICATED THAT THE OPENINGS IN ALL WAFERS WERE MISALIGNED, WITH SOME MORE NOTICEABLY OFF-CENTER THAN OTHERS, RENDERING SEVERAL WAFERS COMPLETELY UNUSABLE FOR HIM. HE CONFIRMED THAT HE HAD NOT USED ANY WAFERS FROM THIS BOX. HE FURTHER EXPLAINED THAT WHEN HE HAD PREVIOUSLY USED PRODUCTS WITH THIS ISSUE, HE HAD BEEN UNABLE TO ACHIEVE A PROPER SEAL. HE EMPHASIZED THAT AN EVENLY CENTERED OPENING WAS CRUCIAL FOR HIM DUE TO THE PRESENCE OF A PARASTOMAL HERNIA. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389330 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE CUSTOMER REPORTED THAT THE PRODUCT OPENINGS IN THE BOX WERE OFF-CENTERED. HE STATED THAT ALL TEN WAFERS IN THE BOX WERE AFFECTED AND NOTED THAT THIS BOX HAD BEEN PROVIDED AS A REPLACEMENT FOR THE SAME ISSUE REPORTED IN A PREVIOUS COMPLAINT. THE CUSTOMER INDICATED THAT THE OPENINGS IN ALL WAFERS WERE MISALIGNED, WITH SOME MORE NOTICEABLY OFF-CENTER THAN OTHERS, RENDERING SEVERAL WAFERS COMPLETELY UNUSABLE FOR HIM. HE CONFIRMED THAT HE HAD NOT USED ANY WAFERS FROM THIS BOX. HE FURTHER EXPLAINED THAT WHEN HE HAD PREVIOUSLY USED PRODUCTS WITH THIS ISSUE, HE HAD BEEN UNABLE TO ACHIEVE A PROPER SEAL. HE EMPHASIZED THAT AN EVENLY CENTERED OPENING WAS CRUCIAL FOR HIM DUE TO THE PRESENCE OF A PARASTOMAL HERNIA. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389329 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE CUSTOMER REPORTED THAT THE PRODUCT OPENINGS IN THE BOX WERE OFF-CENTERED. HE STATED THAT ALL TEN WAFERS IN THE BOX WERE AFFECTED AND NOTED THAT THIS BOX HAD BEEN PROVIDED AS A REPLACEMENT FOR THE SAME ISSUE REPORTED IN A PREVIOUS COMPLAINT. THE CUSTOMER INDICATED THAT THE OPENINGS IN ALL WAFERS WERE MISALIGNED, WITH SOME MORE NOTICEABLY OFF-CENTER THAN OTHERS, RENDERING SEVERAL WAFERS COMPLETELY UNUSABLE FOR HIM. HE CONFIRMED THAT HE HAD NOT USED ANY WAFERS FROM THIS BOX. HE FURTHER EXPLAINED THAT WHEN HE HAD PREVIOUSLY USED PRODUCTS WITH THIS ISSUE, HE HAD BEEN UNABLE TO ACHIEVE A PROPER SEAL. HE EMPHASIZED THAT AN EVENLY CENTERED OPENING WAS CRUCIAL FOR HIM DUE TO THE PRESENCE OF A PARASTOMAL HERNIA. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389327 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE CUSTOMER REPORTED THAT THE PRODUCT OPENINGS IN THE BOX WERE OFF-CENTERED. HE STATED THAT ALL TEN WAFERS IN THE BOX WERE AFFECTED AND NOTED THAT THIS BOX HAD BEEN PROVIDED AS A REPLACEMENT FOR THE SAME ISSUE REPORTED IN A PREVIOUS COMPLAINT. THE CUSTOMER INDICATED THAT THE OPENINGS IN ALL WAFERS WERE MISALIGNED, WITH SOME MORE NOTICEABLY OFF-CENTER THAN OTHERS, RENDERING SEVERAL WAFERS COMPLETELY UNUSABLE FOR HIM. HE CONFIRMED THAT HE HAD NOT USED ANY WAFERS FROM THIS BOX. HE FURTHER EXPLAINED THAT WHEN HE HAD PREVIOUSLY USED PRODUCTS WITH THIS ISSUE, HE HAD BEEN UNABLE TO ACHIEVE A PROPER SEAL. HE EMPHASIZED THAT AN EVENLY CENTERED OPENING WAS CRUCIAL FOR HIM DUE TO THE PRESENCE OF A PARASTOMAL HERNIA. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389322 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE CUSTOMER REPORTED THAT THE PRODUCT OPENINGS IN THE BOX WERE OFF-CENTERED. HE STATED THAT ALL TEN WAFERS IN THE BOX WERE AFFECTED AND NOTED THAT THIS BOX HAD BEEN PROVIDED AS A REPLACEMENT FOR THE SAME ISSUE REPORTED IN A PREVIOUS COMPLAINT. THE CUSTOMER INDICATED THAT THE OPENINGS IN ALL WAFERS WERE MISALIGNED, WITH SOME MORE NOTICEABLY OFF-CENTER THAN OTHERS, RENDERING SEVERAL WAFERS COMPLETELY UNUSABLE FOR HIM. HE CONFIRMED THAT HE HAD NOT USED ANY WAFERS FROM THIS BOX. HE FURTHER EXPLAINED THAT WHEN HE HAD PREVIOUSLY USED PRODUCTS WITH THIS ISSUE, HE HAD BEEN UNABLE TO ACHIEVE A PROPER SEAL. HE EMPHASIZED THAT AN EVENLY CENTERED OPENING WAS CRUCIAL FOR HIM DUE TO THE PRESENCE OF A PARASTOMAL HERNIA. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389238 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE CUSTOMER REPORTED THAT THE PRODUCT OPENINGS IN THE BOX WERE OFF-CENTERED. HE STATED THAT ALL TEN WAFERS IN THE BOX WERE AFFECTED AND NOTED THAT THIS BOX HAD BEEN PROVIDED AS A REPLACEMENT FOR THE SAME ISSUE REPORTED IN A PREVIOUS COMPLAINT. THE CUSTOMER INDICATED THAT THE OPENINGS IN ALL WAFERS WERE MISALIGNED, WITH SOME MORE NOTICEABLY OFF-CENTER THAN OTHERS, RENDERING SEVERAL WAFERS COMPLETELY UNUSABLE FOR HIM. HE CONFIRMED THAT HE HAD NOT USED ANY WAFERS FROM THIS BOX. HE FURTHER EXPLAINED THAT WHEN HE HAD PREVIOUSLY USED PRODUCTS WITH THIS ISSUE, HE HAD BEEN UNABLE TO ACHIEVE A PROPER SEAL. HE EMPHASIZED THAT AN EVENLY CENTERED OPENING WAS CRUCIAL FOR HIM DUE TO THE PRESENCE OF A PARASTOMAL HERNIA. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389237 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE CUSTOMER REPORTED THAT THE PRODUCT OPENINGS IN THE BOX WERE OFF-CENTERED. HE STATED THAT ALL TEN WAFERS IN THE BOX WERE AFFECTED AND NOTED THAT THIS BOX HAD BEEN PROVIDED AS A REPLACEMENT FOR THE SAME ISSUE REPORTED IN A PREVIOUS COMPLAINT. THE CUSTOMER INDICATED THAT THE OPENINGS IN ALL WAFERS WERE MISALIGNED, WITH SOME MORE NOTICEABLY OFF-CENTER THAN OTHERS, RENDERING SEVERAL WAFERS COMPLETELY UNUSABLE FOR HIM. HE CONFIRMED THAT HE HAD NOT USED ANY WAFERS FROM THIS BOX. HE FURTHER EXPLAINED THAT WHEN HE HAD PREVIOUSLY USED PRODUCTS WITH THIS ISSUE, HE HAD BEEN UNABLE TO ACHIEVE A PROPER SEAL. HE EMPHASIZED THAT AN EVENLY CENTERED OPENING WAS CRUCIAL FOR HIM DUE TO THE PRESENCE OF A PARASTOMAL HERNIA. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389234 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE CUSTOMER REPORTED THAT THE PRODUCT OPENINGS IN THE BOX WERE OFF-CENTERED. HE STATED THAT ALL TEN WAFERS IN THE BOX WERE AFFECTED AND NOTED THAT THIS BOX HAD BEEN PROVIDED AS A REPLACEMENT FOR THE SAME ISSUE REPORTED IN A PREVIOUS COMPLAINT. THE CUSTOMER INDICATED THAT THE OPENINGS IN ALL WAFERS WERE MISALIGNED, WITH SOME MORE NOTICEABLY OFF-CENTER THAN OTHERS, RENDERING SEVERAL WAFERS COMPLETELY UNUSABLE FOR HIM. HE CONFIRMED THAT HE HAD NOT USED ANY WAFERS FROM THIS BOX. HE FURTHER EXPLAINED THAT WHEN HE HAD PREVIOUSLY USED PRODUCTS WITH THIS ISSUE, HE HAD BEEN UNABLE TO ACHIEVE A PROPER SEAL. HE EMPHASIZED THAT AN EVENLY CENTERED OPENING WAS CRUCIAL FOR HIM DUE TO THE PRESENCE OF A PARASTOMAL HERNIA. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389228 ↗
• MalfunctionMay 21, 2026Malposition of Device

  THE END USER REPORTED THAT THE OPENING IN THE EIGHT MOLDABLE SKIN BARRIERS WERE OFF CENTERED WHICH MADE THE SKIN BARRIER UNUSABLE. CONSUMER WAS A LONG-TIME USER OF THIS PRODUCT; TYPICAL WEAR TIME WAS FIVE DAYS. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240886 ↗
• MalfunctionMay 21, 2026Malposition of Device

  THE END USER REPORTED THAT THE OPENING IN THE EIGHT MOLDABLE SKIN BARRIERS WERE OFF CENTERED WHICH MADE THE SKIN BARRIER UNUSABLE. CONSUMER WAS A LONG-TIME USER OF THIS PRODUCT; TYPICAL WEAR TIME WAS FIVE DAYS. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240885 ↗
• MalfunctionMay 21, 2026Malposition of Device

  THE END USER REPORTED THAT THE OPENING IN THE EIGHT MOLDABLE SKIN BARRIERS WERE OFF CENTERED WHICH MADE THE SKIN BARRIER UNUSABLE. CONSUMER WAS A LONG-TIME USER OF THIS PRODUCT; TYPICAL WEAR TIME WAS FIVE DAYS. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240884 ↗
• MalfunctionMay 21, 2026Malposition of Device

  THE END USER REPORTED THAT THE OPENING IN THE EIGHT MOLDABLE SKIN BARRIERS WERE OFF CENTERED WHICH MADE THE SKIN BARRIER UNUSABLE. CONSUMER WAS A LONG-TIME USER OF THIS PRODUCT; TYPICAL WEAR TIME WAS FIVE DAYS. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240883 ↗
• MalfunctionMay 21, 2026Malposition of Device

  THE END USER REPORTED THAT THE OPENING IN THE EIGHT MOLDABLE SKIN BARRIERS WERE OFF CENTERED WHICH MADE THE SKIN BARRIER UNUSABLE. CONSUMER WAS A LONG-TIME USER OF THIS PRODUCT; TYPICAL WEAR TIME WAS FIVE DAYS. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240882 ↗
• MalfunctionMay 21, 2026Malposition of Device

  THE END USER REPORTED THAT THE OPENING IN THE EIGHT MOLDABLE SKIN BARRIERS WERE OFF CENTERED WHICH MADE THE SKIN BARRIER UNUSABLE. CONSUMER WAS A LONG-TIME USER OF THIS PRODUCT; TYPICAL WEAR TIME WAS FIVE DAYS. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240881 ↗
• MalfunctionMay 21, 2026Malposition of Device

  THE END USER REPORTED THAT THE OPENING IN THE EIGHT MOLDABLE SKIN BARRIERS WERE OFF CENTERED WHICH MADE THE SKIN BARRIER UNUSABLE. CONSUMER WAS A LONG-TIME USER OF THIS PRODUCT; TYPICAL WEAR TIME WAS FIVE DAYS. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240880 ↗
• MalfunctionMay 21, 2026Malposition of Device

  THE END USER REPORTED THAT THE OPENING IN THE EIGHT MOLDABLE SKIN BARRIERS WERE OFF CENTERED WHICH MADE THE SKIN BARRIER UNUSABLE. CONSUMER WAS A LONG-TIME USER OF THIS PRODUCT; TYPICAL WEAR TIME WAS FIVE DAYS. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240879 ↗
• MalfunctionFeb 7, 2025Malposition of Device; Malposition of Device

  THE DISTRIBUTOR REPORTED THAT THE EDGE OF THE CENTRAL HOLE OF MOLDABLE WAFERS WAS NOT REGULAR, AND THE GLUE OVERFLOWED. THE PRODUCT WAS NOT USED BY THE END USER. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332703 ↗