MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-28 for NON27385 manufactured by Medline Industries Inc..
[186543267]
It was reported that a staff member experienced an allergic reaction during use of the face mask. Reportedly, this occurred over two (2) days of using a face mask from the same box of face masks. On the first day, the staff member noticed a "smell" when the face mask was first put on. She then experienced redness under her eyes, a runny nose, cough, and chest tightness. On each day of face mask use, the staff member took oral benadryl and an unspecified breathing treatment. No additional medical treatment or follow-up care was reported to the manufacturer. A sample was returned to the manufacturer for evaluation and a root cause for the reported incident was unable to be determined. Biocompatibility testing was reviewed for the product and no non-conformances were identified. Due to the reported need for medical treatment, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186543268]
It was reported that a staff member experienced an allergic reaction during use of the face mask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00015 |
| MDR Report Key | 9772045 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-28 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 9311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MASK,FACE,WHITE,HYPOALLERGENIC,FILTER |
| Product Code | FXX |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-13 |
| Catalog Number | NON27385 |
| Lot Number | 85819095023 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-28 |