MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-05-08 for CUR384S manufactured by Medline Industries Inc..
[74631515]
It was reported that the end-user developed an asthma attack after wearing an antiviral face mask. End-user has a known history of pneumonia and asthma and was instructed to wear a face mask in public due to low immunity related to pneumonia. End-user wore the antiviral mask one time with no issue, when she wore a mask a second time she developed an asthmatic response. End-user went to the local emergency department and was treated with inhaled breathing treatments and intravenous magnesium. The symptoms subsided and end-user was discharged home from the emergency department. End-user discarded the face masks and a sample was not returned. A root cause cannot be determined. Due to the reported incident and in an abundance of caution this medwatch is being filed. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[74631516]
It was reported a patient developed an allergic reaction after wearing antiviral facemask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00028 |
| MDR Report Key | 6551280 |
| Report Source | OTHER |
| Date Received | 2017-05-08 |
| Date of Report | 2017-05-08 |
| Date Mfgr Received | 2017-04-27 |
| Date Added to Maude | 2017-05-08 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8477703962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ANTIVIRAL FACEMASK |
| Product Code | OUK |
| Date Received | 2017-05-08 |
| Catalog Number | CUR384S |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-08 |