MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-16 for 3M? HEALTH CARE AURA? PARTICULATE RESPIRATOR AND SURGICAL MASK 1870+ manufactured by 3m Health Care.
[97376702]
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.
Patient Sequence No: 1, Text Type: N, H10
[97376703]
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.
Patient Sequence No: 1, Text Type: D, B5
[102136419]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2018-00009 |
| MDR Report Key | 7195317 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-16 |
| Date of Report | 2018-02-27 |
| Date of Event | 2017-12-29 |
| Date Mfgr Received | 2018-01-15 |
| Device Manufacturer Date | 2017-07-26 |
| Date Added to Maude | 2018-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA JOHNSEN |
| Manufacturer Street | 2510 CONWAY AVE 3M CENTER, BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M U.K., PLC 3M HEALTHCARE |
| Manufacturer Street | HEIGHINGTON LANE |
| Manufacturer City | AYCLIFFE DURHAM DL5 6AF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | DL5 6AF |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? HEALTH CARE AURA? PARTICULATE RESPIRATOR AND SURGICAL MASK |
| Generic Name | SURGICAL APPAREL |
| Product Code | MSH |
| Date Received | 2018-01-16 |
| Returned To Mfg | 2018-01-24 |
| Model Number | 1870+ |
| Catalog Number | 1870+ |
| Lot Number | C172071 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE. 3M CENTER, BUILDING 275-5W-06 ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-01-16 |