Halyard 69252Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 20680651692522), received between Apr 10, 2024 and Jun 24, 2025 — classified as 9 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (26 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT EIGHTEEN. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318849 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT SEVENTEEN. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318791 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT TWENTY-TWO OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318768 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT TWENTY-ONE: OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK; THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318765 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT NINETEEN OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318753 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT TWENTY. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK; THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318751 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT SIXTEEN. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK; THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318741 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT ELEVEN OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK; THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318667 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT FIFTEEN. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318610 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT FOURTEEN. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318605 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT THIRTEEN: OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318589 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT TWELVE. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK; THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318585 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT TEN OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK; THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318517 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT NINE. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318477 ↗
• MalfunctionJun 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT EIGHT. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK; THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318469 ↗
• InjuryJun 23, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT SIX OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Fall

  MAUDE report 22311772 ↗
• InjuryJun 23, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT SEVEN. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK; THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Fall

  MAUDE report 22309902 ↗
• InjuryJun 23, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT FIVE OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK; THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Fall

  MAUDE report 22309801 ↗
• InjuryJun 23, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT FOUR. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Fall

  MAUDE report 22309632 ↗
• InjuryJun 23, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT THREE OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Fall

  MAUDE report 22309631 ↗
• InjuryJun 23, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT TWO: OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Fall

  MAUDE report 22309627 ↗
• InjuryJun 23, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT ONE: OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

  Patient problems: Fall

  MAUDE report 22309617 ↗
• MalfunctionJan 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT ONE: (B)(6) HOSPITAL HAS HAD SEVERAL FALLS IN THEIR L&D AREA. CUSTOMER SUSPECTS IT COULD HAVE SOMETHING TO DO WITH RESIDUAL POWDER OR SOMETHING COMING OFF THE SHOE COVERS. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2025, WITH NO RESPONSE RECEIVED BACK FROM THE CUSTOMER. BASED ON COMPLAINT REPORT WITH MINIMAL INFORMATION, AT THIS TIME IT'S UNKNOWN IF THERE WERE ANY SERIOUS INJURIES OR MEDICAL INTERVENTION REQUIRED DUE TO REPORTED FALLS. THE CUSTOMER ALSO DID NOT PROVIDE A LOT NUMBER.

  Patient problems: Fall

  MAUDE report 21235931 ↗
• MalfunctionJan 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT (B)(6) HAS HAD SEVERAL FALLS IN THEIR L&D AREA. CUSTOMER SUSPECTS IT COULD HAVE SOMETHING TO DO WITH RESIDUAL POWDER OR SOMETHING COMING OFF THE SHOE COVERS. ADDITIONAL INFORMATION WAS REQUESTED ON JANUARY 14, 2025, JANUARY 15, 2025, AND JANUARY 16, 2025, WITH NO RESPONSE RECEIVED BACK FROM THE CUSTOMER. BASED ON COMPLAINT REPORT WITH MINIMAL INFORMATION, AT THIS TIME IT'S UNKNOWN IF THERE WERE ANY SERIOUS INJURIES OR MEDICAL INTERVENTION REQUIRED DUE TO REPORTED FALLS. THE CUSTOMER ALSO DID NOT PROVIDE A LOT NUMBER.

  Patient problems: Fall

  MAUDE report 21235564 ↗
• InjuryApr 10, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT TWO PER CUSTOMER THEY HAVE SOME CONCERNS WITH THE TRACTION OF THE SHOE COVERS THEY'VE RECEIVED. THEY'VE HAD STAFF MEMBERS SLIP AND FALL WHILE WEARING THEM. THE SECOND INCIDENT OCCURRED ON FEBRUARY 15, 2024. FOR THIS INCIDENT IN FEBRUARY, THE EMPLOYEE WAS PUT ON MODIFIED DUTY DUE TO INJURY TO THE LOWER BACK AND WRIST FROM THE FALL. THERE WAS NO HOSPITAL STAY FOR THIS PATIENT.

  Patient problems: Fall

  MAUDE report 19085263 ↗