SUR-FIT NATURA 401502Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00768455103232), received between Nov 8, 2021 and Nov 8, 2021 — classified as 7 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 12771669 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED AN ONGOING ISSUE WITH UNKNOWN NUMBER OF CLIPS FROM AN UNKNOWN NUMBER OF BOXES. SHE SUSPECTS THAT IT IS A TOTAL OF 5 CLIPS. SHE HAD LEAKAGE FROM TAIL CLOSURE OF POUCH WHEN IT THE CLIP CRACKED WHICH CAUSED A URINARY TRACT INFECTION (UTI) AND SHE HAD TO TAKE ANTIBIOTICS DUE TO UTI. THE LABORATORY RESULT SHOWED E-COLI IN THE URINE AND WAS STARTED ON AN UNKNOWN ANTIBIOTIC. AT THE TIME OF THIS REPORT THE PATIENT CONTINUED USING THE PRODUCT. THE PRODUCT WAS USED BY END USER AND NO PHOTO AVAILABLE AT THIS TIME.

  Patient problems: Urinary Tract Infection

  MAUDE report 12771608 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED AN ONGOING ISSUE WITH UNKNOWN NUMBER OF CLIPS FROM AN UNKNOWN NUMBER OF BOXES. SHE SUSPECTS THAT IT IS A TOTAL OF 5 CLIPS. SHE HAD LEAKAGE FROM TAIL CLOSURE OF POUCH WHEN IT THE CLIP CRACKED WHICH CAUSED A URINARY TRACT INFECTION (UTI) AND SHE HAD TO TAKE ANTIBIOTICS DUE TO UTI. THE LABORATORY RESULT SHOWED E-COLI IN THE URINE AND WAS STARTED ON AN UNKNOWN ANTIBIOTIC. AT THE TIME OF THIS REPORT THE PATIENT CONTINUED USING THE PRODUCT. THE PRODUCT WAS USED BY END USER AND NO PHOTO AVAILABLE AT THIS TIME.

  Patient problems: Urinary Tract Infection

  MAUDE report 12771607 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED AN ONGOING ISSUE WITH UNKNOWN NUMBER OF CLIPS FROM AN UNKNOWN NUMBER OF BOXES. SHE SUSPECTS THAT IT IS A TOTAL OF 5 CLIPS. SHE HAD LEAKAGE FROM TAIL CLOSURE OF POUCH WHEN IT THE CLIP CRACKED WHICH CAUSED A URINARY TRACT INFECTION (UTI) AND SHE HAD TO TAKE ANTIBIOTICS DUE TO UTI. THE LABORATORY RESULT SHOWED E-COLI IN THE URINE AND WAS STARTED ON AN UNKNOWN ANTIBIOTIC. AT THE TIME OF THIS REPORT THE PATIENT CONTINUED USING THE PRODUCT. THE PRODUCT WAS USED BY END USER AND NO PHOTO AVAILABLE AT THIS TIME.

  Patient problems: Urinary Tract Infection

  MAUDE report 12771605 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED AN ONGOING ISSUE WITH UNKNOWN NUMBER OF CLIPS FROM AN UNKNOWN NUMBER OF BOXES. SHE SUSPECTS THAT IT IS A TOTAL OF 5 CLIPS. SHE HAD LEAKAGE FROM TAIL CLOSURE OF POUCH WHEN IT THE CLIP CRACKED WHICH CAUSED A URINARY TRACT INFECTION (UTI) AND SHE HAD TO TAKE ANTIBIOTICS DUE TO UTI. THE LABORATORY RESULT SHOWED E-COLI IN THE URINE AND WAS STARTED ON AN UNKNOWN ANTIBIOTIC. AT THE TIME OF THIS REPORT THE PATIENT CONTINUED USING THE PRODUCT. THE PRODUCT WAS USED BY END USER AND NO PHOTO AVAILABLE AT THIS TIME.

  Patient problems: Urinary Tract Infection

  MAUDE report 12771604 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 12771603 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED AN ONGOING ISSUE WITH UNKNOWN NUMBER OF CLIPS FROM AN UNKNOWN NUMBER OF BOXES. SHE SUSPECTS THAT IT IS A TOTAL OF 5 CLIPS. SHE HAD LEAKAGE FROM TAIL CLOSURE OF POUCH WHEN IT THE CLIP CRACKED WHICH CAUSED A URINARY TRACT INFECTION (UTI) AND SHE HAD TO TAKE ANTIBIOTICS DUE TO UTI. THE LABORATORY RESULT SHOWED E-COLI IN THE URINE AND WAS STARTED ON AN UNKNOWN ANTIBIOTIC. AT THE TIME OF THIS REPORT THE PATIENT CONTINUED USING THE PRODUCT. THE PRODUCT WAS USED BY END USER AND NO PHOTO AVAILABLE AT THIS TIME.

  Patient problems: Urinary Tract Infection

  MAUDE report 12771602 ↗