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 Codes	Corneal Ulcer (1796); Inflammation (1932); Eye Pain (4467)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number and expiration date are not available.Manufacture date not available.Product has been discarded; therefore, not returned to 3m¿ for analysis.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.
Event or Problem Description
A (b)(6)-year-old white female nurse reported bilateral swollen eyelids, skin and eye redness, stinging and ulceration after wearing 3m¿ 1860 n95 respirator mask and a face shield.Medical history includes an eye sensitivity to chemical odors including new manufactured homes, new cars, and new furniture.Symptoms started approximately after 4 hours of wear.The nurse went home and administered over the counter eye drops and an antihistamine with some relief.The following day she was experiencing light sensitivity.She reported going to the emergency room and was prescribed a prophylactic antibiotic, steroid eye drops, and antihistamine eye drops.Monday she was seen by an ophthalmologist and they indicated basement membrane dystrophy.Etiology of basement membrane dystrophy is unknown.Symptoms resolved to baseline after completion of prescriptions.(b)(6) 2021, she experienced the same sensitivity.Eye drops were re-prescribed and symptoms are resolved.No permanent damage reported.No further information.

• 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: 13773978
• Report Number: 2110898-2022-00023
• Device Sequence Number: 1765475
• Product Code: FXX
• UDI-Device Identifier: 38887719257399
• UDI-Public: 38887719257399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

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 Model Number: N/A
• Device Catalogue Number: 1860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White