MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-26 for CVS310410W manufactured by Medline Industries Inc..
[137168904]
It was reported that end-user required treatment with steroids for allergic reaction to face mask. Per report, the end-user developed redness to bilateral cheeks and to area under the nose. Reportedly, the end-user wore the facemasks for five days, approximately 80% of the time. The end-user's symptoms reportedly resolved after two to three weeks. Of note, the end-user stated that she is "very sensitive" and added, "i also took oregano oil maybe that could have caused this (allergic reaction) too. " due to the reported incident and required medical intervention, this medwatch is being filed. Samples are not available to be returned for evaluation. A root cause could not be identified 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
[137168965]
It was reported that end-user required treatment with steroids for allergic reaction to face mask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00025 |
| MDR Report Key | 8370385 |
| Report Source | CONSUMER |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-26 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-01-31 |
| Date Added to Maude | 2019-02-26 |
| 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 | FACE MASK,PROCEDURAL , EARLOOPS, BLUE,LF |
| Product Code | FXX |
| Date Received | 2019-02-26 |
| Catalog Number | CVS310410W |
| Lot Number | 85817118311 |
| 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 | 2019-02-26 |