MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ HEALTH CARE AURA¿ PARTICULATE RESPIRATOR AND SURGICAL MASK; SURGICAL APPAREL

Model Number	1870+
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Respiratory Distress (2045); Patient Problem/Medical Problem (2688)
Date of Event	12/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt identifier and weight: no information provided.This type of reported event is rare.The product is not made with natural rubber latex.The doctor mentioned the steroid given was probably solu-medrol (methylprednisolone).The product used is no longer available and will not be sent in for evaluation.End of report.
Event or Problem Description
An occupational health worker alleged that a female, who is a registered nurse (rn), wore a surgical respirator to perform patient care for an isolation patient.Within thirty minutes of wearing the surgical respirator, she began to feel strange and thought she smelled latex in the surgical respirator.After removal of the surgical respirator, the rn continued to feel unwell, was seen in the emergency room, and then admitted to the hospital critical care unit, where she remained over the weekend.A medical doctor who is an allergist contacted 3m and alleged that the rn experienced anaphylaxis, where the symptoms included shortness of breath, throat tightness, profuse rhinorrhea and hypotension, which resulted after the first-time use of this type of surgical respirator worn by the rn.The rn was hospitalized the same day on (b)(6) 2017, and was discharged on (b)(6) 2017.She was given epinephrine, steroids and an antihistamine in the emergency room, and therapy was continued with epinephrine and steroids during the hospital stay.The current status of the (rn) is fine according to the doctor.
Additional Manufacturer Narrative
Information obtained on february 15, 2018 indicates: (b)(4) samples were received and visually reviewed with no abnormalities observed, and no abnormal odor noticed.Complaints were reviewed from complaints were reviewed from january 1, 2016 to december 31, 2017; there has been a total of (b)(4) medical complaints received, where one involved an anaphylactic reaction in addition to this current complaint.The additional complaint did not have the same lot number as this complaint.End of report.

• Brand Name: 3M¿ HEALTH CARE AURA¿ PARTICULATE RESPIRATOR AND SURGICAL MASK
• Common Device Name: SURGICAL APPAREL
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave.; 3m center, building 275-5w-06; st. paul MN 55144
• MDR Report Key: 7195317
• Report Number: 2110898-2018-00009
• Device Sequence Number: 11137355
• Product Code: MSH
• UDI-Device Identifier: 00051131499966
• UDI-Public: 00051131499966
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: Nurse
• Device Expiration Date: 07/26/2022
• Device Model Number: 1870+
• Device Catalogue Number: 1870+
• Device Lot Number: C172071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2017
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 49 YR