MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-09 for NON27382Z manufactured by Medline Industries Inc..
[132497832]
It was reported that after eight hours of wearing the chamber-style surgical face mask, upon taking the facemask off, the nurse noted "red, raised, hot skin on the right side of my face, as well as tightening in my throat". Per report, the nurse immediately went to the emergency department where she was given steroids and an epinephrine injection. The nurse reportedly has allergies to penicillin and clams. Due to the reported incident and need for medical intervention, this medwatch is being filed. Samples are not available to be returned for evaluation. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[132497833]
It was reported that the nurse developed allergic reaction to the surgical facemask and the nurse required treatment with steroids and epinephrine injection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00142 |
| MDR Report Key | 8230910 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-09 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2019-01-09 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MASK,FACE,GREEN,CHAMBER,TIES,LF |
| Product Code | FXX |
| Date Received | 2019-01-09 |
| Catalog Number | NON27382Z |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-01-09 |