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 2017-01-06 for 3M(TM) VFLEX(TM) HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 1870 manufactured by 3m Health Care.
[64121684]
It was not clear if mask used by the user was used more than one day. Improper storage may have contributed to this event. It was not clear what type of sealed bag the facility was using to store mask in nor if product linked to event was stored in the sealed bag.
Patient Sequence No: 1, Text Type: N, H10
[64121685]
A report and questionnaire was received from a female nurse on (b)(6) 2016. The female nurse allege that on (b)(6) 2016 she immediately broke out in a rash, and had redness, experienced itching around her eyes and neck and under the mask she was wearing. She alleged she had donned a 3m? Vflex? Health care particulate respirator and surgical mask. She had used a mask for 2 days without any incident. Note: it was not clear if it was the same, new or different mask. The female was seen in the emergency room on the day of the incident where she was given decadron (dexamethasone) (route not specified), benadryl (diphenhydramine), and pepcid (famotidine). It was indicated the mask was stored in a sealed bag. She claimed to have no known allergies. She reported there were no known environmental issues at the time of the reaction. The doctor who attended the nurse stated she, "may have an allergy to the rubber contents of the mask". Note: initial information received on (b)(6) 2016 did not indicate the nature of medical intervention. It did include information that suggested the nurse may have an allergy to rubber contents of the mask due to reaction around eyes and neck. Please note the 3m? Vflex? Health care particulate respirator and surgical mask is not made with natural rubber latex.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00003 |
| MDR Report Key | 6231103 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-06 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-10-30 |
| Date Mfgr Received | 2017-12-09 |
| Date Added to Maude | 2017-01-06 |
| 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 | MS. LINDA JOHNSEN |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M U.K., PLC |
| 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(TM) VFLEX(TM) HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK |
| Generic Name | RESPIRATOR SURGICAL MASK |
| Product Code | MSH |
| Date Received | 2017-01-06 |
| Catalog Number | 1870 |
| Lot Number | UNK |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-06 |