Halyard 46727Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 20680651467274), received between May 5, 2020 and May 23, 2025 — classified as 8 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INCIDENT THREE. HOSPITAL (B)(6) HAD A TB OUTBREAK. THE HOSPITAL (B)(6) OSH UNIT COLLABORATED WITH NIOSH MALAYSIA AND PERFORMED N95 FIT TESTING USING QUANTITATIVE TEST METHOD FOLLOWING THE OSHA FIT TEST PROTOCOL. STAFF WEARING THE PRODUCT WHILE PERFORMING THE TEST FAILED. ADDITIONAL INCIDENT QUESTIONS WERE ASKED TO THE END-USER. ON APRIL 28, 2025, THE END-USER PROVIDED INFORMATION THAT FIVE EMPLOYEES FROM HOSPITAL (B)(6) EMERGENCY DEPARTMENT HAD CONTRACTED TB DURING TIME PERIOD (B)(6) 2025. THESE EMPLOYEES WERE ALL TREATED FOR TB AND HAVE SINCE MOVED FROM INTENSIVE TREATMENT TO MAINTENANCE (FURTHER DETAILS OF TREATMENT WERE NOT PROVIDED). ACCORDING TO HOSPITAL, THEY DO NOT FIT TEST ALL WEARERS PRIOR TO USE. THEY ONLY FIT TEST A CERTAIN QUANTITY OF WORKERS. THEY WERE UNABLE TO SHARE WHETHER THESE PARTICULAR EMPLOYEES WERE FIT TESTED UTILIZING THE HALYARD CODE PRIOR TO CONTRACTING TB. THERE IS A PRECAUTION ON THE PRODUCT LABELING ADVISING END-USERS TO PERFORM FIT TESTING. THE HOSPITAL UTILIZES BOTH THE HALYARD MASK PRODUCT REPORTED IN THIS DEVICE REPORT AS WELL AS A 3M MASK. ACCORDING TO THE HOSPITAL, THE EMPLOYEES WEAR WHICHEVER IS AVAILABLE AT THE TIME OF NEED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22078980 ↗
• InjuryMay 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INCIDENT FIVE. HOSPITAL (B)(6) HAD A TB OUTBREAK. THE HOSPITAL (B)(6) OSH UNIT COLLABORATED WITH (B)(6) AND PERFORMED N95 FIT TESTING USING QUANTITATIVE TEST METHOD FOLLOWING THE OSHA FIT TEST PROTOCOL. STAFF WEARING THE PRODUCT WHILE PERFORMING THE TEST FAILED. ADDITIONAL INCIDENT QUESTIONS WERE ASKED TO THE END-USER. ON (B)(6) 2025, THE END-USER PROVIDED INFORMATION THAT FIVE EMPLOYEES FROM HOSPITAL (B)(6) EMERGENCY DEPARTMENT HAD CONTRACTED TB DURING TIME PERIOD ON (B)(6) 2025. THESE EMPLOYEES WERE ALL TREATED FOR TB AND HAVE SINCE MOVED FROM INTENSIVE TREATMENT TO MAINTENANCE (FURTHER DETAILS OF TREATMENT WERE NOT PROVIDED). ACCORDING TO HOSPITAL, THEY DO NOT FIT TEST ALL WEARERS PRIOR TO USE. THEY ONLY FIT TEST A CERTAIN QUANTITY OF WORKERS. THEY WERE UNABLE TO SHARE WHETHER THESE PARTICULAR EMPLOYEES WERE FIT TESTED UTILIZING THE HALYARD CODE PRIOR TO CONTRACTING TB. THERE IS A PRECAUTION ON THE PRODUCT LABELING ADVISING END-USERS TO PERFORM FIT TESTING. THE HOSPITAL UTILIZES BOTH THE HALYARD MASK PRODUCT REPORTED IN THIS DEVICE REPORT AS WELL AS A 3M MASK. ACCORDING TO THE HOSPITAL, THE EMPLOYEES WEAR WHICHEVER IS AVAILABLE AT THE TIME OF NEED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22076881 ↗
• InjuryMay 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INCIDENT FOUR, HOSPITAL (B)(6) HAD A TB OUTBREAK. THE HOSPITAL (B)(6) OSH UNIT COLLABORATED WITH NIOSH MALAYSIA AND PERFORMED N95 FIT TESTING USING QUANTITATIVE TEST METHOD FOLLOWING THE OSHA FIT TEST PROTOCOL. STAFF WEARING THE PRODUCT WHILE PERFORMING THE TEST FAILED. ADDITIONAL INCIDENT QUESTIONS WERE ASKED TO THE END-USER. ON APRIL 28, 2025, THE END-USER PROVIDED INFORMATION THAT FIVE EMPLOYEES FROM HOSPITAL (B)(6) EMERGENCY DEPARTMENT HAD CONTRACTED TB DURING TIME PERIOD (B)(6) 2025. THESE EMPLOYEES WERE ALL TREATED FOR TB AND HAVE SINCE MOVED FROM INTENSIVE TREATMENT TO MAINTENANCE (FURTHER DETAILS OF TREATMENT WERE NOT PROVIDED). ACCORDING TO HOSPITAL, THEY DO NOT FIT TEST ALL WEARERS PRIOR TO USE. THEY ONLY FIT TEST A CERTAIN QUANTITY OF WORKERS. THEY WERE UNABLE TO SHARE WHETHER THESE PARTICULAR EMPLOYEES WERE FIT TESTED UTILIZING THE HALYARD CODE PRIOR TO CONTRACTING TB. THERE IS A PRECAUTION ON THE PRODUCT LABELING ADVISING END-USERS TO PERFORM FIT TESTING. THE HOSPITAL UTILIZES BOTH THE HALYARD MASK PRODUCT REPORTED IN THIS DEVICE REPORT AS WELL AS A 3M MASK. ACCORDING TO THE HOSPITAL, THE EMPLOYEES WEAR WHICHEVER IS AVAILABLE AT THE TIME OF NEED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22076876 ↗
• InjuryMay 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INCIDENT TWO. HOSPITAL (B)(6) HAD A TB OUTBREAK. THE HOSPITAL (B)(6) OSH UNIT COLLABORATED WITH (B)(6) AND PERFORMED N95 FIT TESTING USING QUANTITATIVE TEST METHOD FOLLOWING THE OSHA FIT TEST PROTOCOL. STAFF WEARING THE PRODUCT WHILE PERFORMING THE TEST FAILED. ADDITIONAL INCIDENT QUESTIONS WERE ASKED TO THE END-USER. ON (B)(6) 2025, THE END-USER PROVIDED INFORMATION THAT FIVE EMPLOYEES FROM HOSPITAL (B)(6) EMERGENCY DEPARTMENT HAD CONTRACTED TB DURING TIME PERIOD ON (B)(6) 2025. THESE EMPLOYEES WERE ALL TREATED FOR TB AND HAVE SINCE MOVED FROM INTENSIVE TREATMENT TO MAINTENANCE (FURTHER DETAILS OF TREATMENT WERE NOT PROVIDED). ACCORDING TO HOSPITAL, THEY DO NOT FIT TEST ALL WEARERS PRIOR TO USE. THEY ONLY FIT TEST A CERTAIN QUANTITY OF WORKERS. THEY WERE UNABLE TO SHARE WHETHER THESE PARTICULAR EMPLOYEES WERE FIT TESTED UTILIZING THE HALYARD CODE PRIOR TO CONTRACTING TB. THERE IS A PRECAUTION ON THE PRODUCT LABELING ADVISING END-USERS TO PERFORM FIT TESTING. THE HOSPITAL UTILIZES BOTH THE HALYARD MASK PRODUCT REPORTED IN THIS DEVICE REPORT AS WELL AS A 3M MASK. ACCORDING TO THE HOSPITAL, THE EMPLOYEES WEAR WHICHEVER IS AVAILABLE AT THE TIME OF NEED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22076866 ↗
• InjuryApr 2, 2025Component Incompatible; Appropriate Device Problem Term/Code Not Available; Component Incompatible; Appropriate Device Problem Term/Code Not Available

  (B)(6) HAD A TB OUTBREAK. THE (B)(6) OSH UNIT COLLABORATED WITH (B)(6) AND PERFORMED N95 FIT TESTING USING QUANTITATIVE TEST METHOD FOLLOWING THE OSHA FIT TEST PROTOCOL. STAFF WEARING THE PRODUCT WHILE PERFORMING THE TEST FAILED. AT THIS TIME, IT IS UNCLEAR WHETHER THE HOSPITAL PERFORMED FIT TESTING PRIOR TO THE REPORTED OUTBREAK OR WHAT QUANTITY OF END-USERS WERE AFFECTED BY TB.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21753541 ↗
• MalfunctionDec 12, 2023Component Incompatible; Component Incompatible

  AN ANONYMOUS AMAZON REVIEW WAS RECEIVED WHICH INDICATES WHILE WEARING THE MASK, THE CUSTOMER GOT STYES ON TWO SEPARATE OCCASIONS. ADDITIONAL QUESTIONS WERE REQUESTED FROM AMAZON (THE CUSTOMER), NO RESPONSE HAS BEEN RECEIVED TO-DATE.

  Patient problems: Local Reaction

  MAUDE report 18314266 ↗
• InjurySep 14, 2023Component Incompatible; Component Incompatible

  A MEDWATCH REPORT (MW5145095) WAS RECEIVED THROUGH FDA¿S MEDWATCH PROGRAM ON (B)(6) 2023. THE CUSTOMER CONTRACTED COVID-19 AND WAS FULLY VACCINATED. CUSTOMER INDICATED THEY WERE EXTREMELY CAREFUL WEARING A CLEAN HALYARD N95 DUCKBILL MASK. ALMOST A YEAR LATER THE CUSTOMER STILL SUFFERS WITH LONG-TERM COVID SYMPTOMS AND SIDE EFFECTS THAT ARE IMPACTING THEIR HEALTH AND WELLNESS. THE INITIAL BINAXNOW COVID-19 TEST WAS CONFIRMED WITH IHEALTH AND SENT TO THE CDC. CUSTOMER SUBSEQUENTLY INDICATED THEY SUSPECTED THEY CAUGHT COVID ON A PLANE FROM LONDON TO SFO. CUSTOMER WAS MASKED ON THE PLANE FLIGHT OTHER THAN WHEN QUICKLY EATING. THERE WAS NO MEDICAL INTERVENTION OTHER THAN OVER THE COUNTER MEDICATION. THE CUSTOMER INDICATED THEY HAVE RESIDUAL FATIGUE, MUSCLE ACHES, TINGLING FEET AND ELBOW, OVERACTIVE BLADDER, AND INCREASE IN HEMOGLOBIN. CUSTOMER FOLLOWS UP WITH PHYSICIAN REGULARLY BUT NEVER HAD ANY OF THESE ISSUES PRIOR TO CONTRACTING VIRUS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17749154 ↗
• MalfunctionJun 30, 2023Break; Break

  CUSTOMER REPORTED 15 OR MORE INDIVIDUALS HAVE ISSUED COMPLAINTS AROUND THE N95 STRAPS DETACHING FROM THE CORNER. IT WAS REPORTED THIS OCCURRED WHILE THE RN WAS WEARING THE N95 IN ROOM. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243810 ↗
• MalfunctionJun 30, 2023Break; Break

  THE N95 DUCK-TYPE MASKS ARE BREAKING. IT WAS REPORTED THIS OCCURRED DURING USE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243803 ↗
• MalfunctionJun 20, 2023Break; Break

  WE HAVE EXPERIENCED BOTH REGULAR AND SMALL SIZES BREAKING IN THE STRAP AREA CONNECTED TO THE MASK. INCIDENT WAS REPORTED TO HAVE OCCURRED DURING PRODUCT USE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167922 ↗
• MalfunctionJun 19, 2023Break; Break

  "I DID RECEIVE A HEADS UP FROM OUR MED/SURG MANAGER LAST NIGHT THAT A COUPLE OF THEIR USERS RECENTLY HAD BEEN EXPERIENCING THE STRAPS ON THE MASK BREAKING EASILY, CAUSING AN INCREASE IN USAGE". INCIDENT WAS REPORTED TO HAVE OCCURRED DURING PRODUCT USE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151978 ↗
• MalfunctionJun 16, 2023Break; Break

  EAR LOOPS CAME OFF WHILE BEING WORN, DURING USE. THERE WAS NO MEDICAL TREATMENT OR SURGICAL INTERVENTION REQUIRED. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17140923 ↗
• MalfunctionJun 14, 2023Break; Break

  CUSTOMER INDICATES THAT THE BOX OF MASKS HAD THREE BREAKS LAST NIGHT. THE INCIDENT WAS REPORTED TO HAVE OCCURRED DURING USE. THERE WERE THREE ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION; HOWEVER, THEY HAVE NOT RESPONDED. NO INJURY OR ILLNESS WAS INDICATED. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132114 ↗
• MalfunctionJun 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MASK STRAPS BREAK WHILE ATTEMPTING TO WEAR. THE N95 MASK IS USED FOR COVID 19 PATIENTS. THE MASKS ARE BREAKING DURING USE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114331 ↗
• MalfunctionJun 12, 2023Product Quality Problem; Product Quality Problem

  ONE OF THE ELASTIC BANDS OF N95 CAME LOOSE AND PERSONNEL WAS EXPOSED FOR A FEW SECONDS WHILE PROVIDING FOR PATIENT WITH COVID 19. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. PLEASE NOTE THAT IN THIS INCIDENT, THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106775 ↗
• MalfunctionJun 9, 2023Break; Break

  THE MASKS EXHIBITED THE FOLLOWING ISSUES; MISSING HEADBANDS, HEADBANDS BREAKING/DETACHING, HOLE IN THE MASK MATERIAL, MASK DUCKBILL PORTION SEPARATING/NOT SEALED, INNER LAYERS COMES APART. THE CUSTOMER STATED A CLINICIAN IN THE EMERGENCY ROOM WAS WORKING WITH A PATIENT AND NOTICED A HOLE IN THE MASK. THE CLINICIAN WAS CONCERNED ABOUT EXPOSURE TO COVID-19. THE CLINICIAN DID NOT REPORT ANY INJURY, SYMPTOMS, TESTING OR OTHER MEDICAL INTERVENTION PERFORMED. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17101766 ↗
• MalfunctionJun 9, 2023Break; Break

  THE BAND PULLED AWAY FROM THE MASK (IN A COVID ROOM). A LEVEL ONE COVER WAS OVER THE TOP TO HOLD THE MASK IN PLACE. THERE HAVE BEEN OTHER INSTANCES WHERE THE BANDS BROKE TRYING TO PUT ON MASK OR BROKE AFTER THEY PUT THE MASK ON. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17101764 ↗
• MalfunctionJun 8, 2023Break; Break

  THE CUSTOMER USED THE N-95 AND THE FRONT SEAM OF THE DUCKBILL MASK IS SEPARATING. THIS WAS REPORTED TO HAVE OCCURRED DURING USE. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER, HOWEVER, THE REPORTER DID NOT PROVIDE RESPONSE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088042 ↗
• MalfunctionJun 6, 2023Material Integrity Problem; Material Integrity Problem

  INCIDENT TWO: "SURGEON WAS WEARING ABOVE PRODUCT DURING SURGICAL CASE. THE STRAPS ON THE N95 BROKE EARLY IN THE CASE AND THE MASK FELL ONTO THE STERILE FIELD CONTAMINATING THE SURGEON'S RIGHT HAND, THE INSTRUMENT IN HIS HAND AND THEN FELL ONTO THE PATIENT'S DRAPE. THE SURGEON HAD TO STOP HIS PROCEDURE, HAND OFF CONTAMINATED INSTRUMENT, CHANGE GLOVES, AND COVER THE DRAPED AREA WITH NEW DRAPES" THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076247 ↗
• MalfunctionJun 6, 2023Material Integrity Problem; Material Integrity Problem

  INCIDENT ONE: "SEVERAL DIFFERENT EPISODES OF THE STRAPS BREAKING ON THIS MASK BOTH DURING APPLICATIONS AS WELL AS MID STERILE PROCEDURE. TODAY WHILE SCRUBBED INTO A HEART CATH THE TOP STRAP BROKE ON THE MASK. DR.(B)(6) WOULD LIKE TO ADD THAT THIS ALSO HAPPENED DURING A PROCEDURE ON A CODE HEART WITH UNKNOWN COVID STATUS POTENTIALLY EXPOSING THE PHYSICIAN TO COVID. THIS IS OCCURRING DESPITE PRE-APPLICATION STRETCHING AS WELL NO PRE-APPLICATION STRETCHING." THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076223 ↗
• InjuryMay 24, 2023Protective Measures Problem; Protective Measures Problem

  A MEDWATCH REPORT (MW5116813), WAS RECEIVED ON (B)(6)2023 FROM THE FDA¿S MEDWATCH PROGRAM FOR A VIRAL INFECTION (COVID). I AM A PRIMARY CARE PHYSICIAN AND I HAD A HUGE BOX OF THESE RESPIRATORS FROM 2022 THAT I RECENTLY USED UP AND JUST STARTED USING A NEWLY ORDERED BOX WHICH I RECEIVED IN (B)(6)2023. I TOOK A RAPID COVID TEST BEFORE VISITING MY PARENTS, AND I WAS SOMEWHAT SURPRISED TO SEE A POSITIVE RESULT. MY IMMEDIATE FAMILY ALL TESTED NEGATIVE.

  Patient problems: Viral Infection

  MAUDE report 16991955 ↗
• MalfunctionMay 8, 2023Break; Break

  WHILE THE NURSE WAS PROVIDING PATIENT CARE ON A COVID POSITIVE PATIENT, THE STRAPS BROKE AT THE CORNER OF THE MASK. THE CLINICIAN REPORTED NO INJURY, NO SYMPTOMS, NO MEDICAL INTERVENTION OR MEDICAL TESTING OR TREATMENT PERFORMED. THE CUSTOMER REPORTED THAT THIS HAS OCCURRED OVER THE PAST SEVERAL MONTHS AND THE CLINICIANS WERE STAPLING THE STRAPS TO THE MASKS, THEY HAVE SINCE DISCONTINUED THAT PRACTICE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. PLEASE NOTE THAT IN THIS INCIDENT, THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16885416 ↗
• MalfunctionMay 3, 2023Break; Break

  THE DISTRIBUTOR REPORTED THAT DEFECTIVE HEADBANDS TEAR DURING USE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER OR PATIENT MAY BE AT AN INCREASED RISK OF CONTRACTING A PATHOGEN. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. PLEASE NOTE THAT IN THIS INCIDENT, THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16865136 ↗
• InjuryMay 5, 2020Component Incompatible; Component Incompatible

  IT WAS REPORTED BY THE CUSTOMER WHO STATED THAT SHE EXPERIENCED A SKIN RASH ON HER FACE AFTER WEARING THE MASK FOR A 12 HOUR PERIOD. SHE WAS SEEN BY EMPLOYEE HEALTH IN THE EMERGENCY ROOM AND HAD A TELEMEDICINE CONSULT WITH A PHYSICIAN AS A FOLLOW UP. THE CUSTOMER STATED SHE WAS PRESCRIBED A TOPICAL STEROID CREAM. THE ISSUE WAS RESOLVED BY SWITCHING TO A DIFFERENT MASK. THE CUSTOMER STATES THAT SHE HAS A HISTORY OF EXISTING ALLERGIES AND CARRIES AN EPIPEN. THE CUSTOMER STATED SHE EXPERIENCED SHORTNESS OF BREATH WEARING "A MASK" BUT SHE STATES SHE IS UNSURE IF THE SOB OCCURRED WITH A HALYARD MASK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Reaction

  MAUDE report 10024218 ↗