MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK; SURGICAL/MEDICAL RESPIRATOR, NON-ANTIMICROBIAL, SINGLE-USE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A hospital reported a female staff member experienced chest tightness and shortness of breath after donning 3m¿ health care particulate respirator and surgical mask 1860.The mask was reported to have small particle(s) in the mask and upon donning the particle was inhaled causing her to choke.Code blue was initiated.Vitals remained stable with 100% spo2 on room air.After five minutes staff member appeared calmer and was able to communicate, she still felt something stuck in her throat and chest tightness.Ventolin nebulizer was administered, patient was reassessed and discharged as symptoms resolved.No further information.
Additional Manufacturer Narrative
Eleven samples were returned to 3m.Unknown if the actual sample mask worn is included in the samples received.3m¿ takes very seriously the safety of our products and we review the possible causes of all complaints.Since the intended use of this product includes skin contact, the materials used in the respirator have been evaluated by toxicologists in the 3m medical department paying particular attention to base chemicals and raw materials which might pose risk for dermal irritation, allergy, or toxicity.Based on these reviews, no risk for adverse health effects is expected when the respirator is used as intended and following instructions for use.3m will continue to monitor.Additionally, the manufacturing locations have processes for controlling contamination during the manufacturing of the product.The areas where medical device respirator is manufactured have specific approved processing aides which can be used.For those aides which could come into contact with the product, toxicological reviews have been performed.In addition, the manufacturing line is cleaned with approved supplies as part of the contamination control procedures.

• Brand Name: 3M¿ HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
• Common Device Name: SURGICAL/MEDICAL RESPIRATOR, NON-ANTIMICROBIAL, SINGLE-USE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M SINGAPORE-3MSG-TUAS; 01gdzt20: no 2 tuas link 4; tuas west road; singapore, ; SN
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 13472869
• Report Number: 2110898-2022-00010
• Device Sequence Number: 4690420
• Product Code: FXX
• UDI-Device Identifier: 38887719257399
• UDI-Public: 38887719257399
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K955382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2025
• Device Model Number: N/A
• Device Catalogue Number: 1860
• Device Lot Number: R20043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female