SURGICAL MASK Adverse Event — Malfunction (MDR MW5094263)
SURGICAL MASK Adverse Event — Malfunction (MDR MW5094263) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SURGICAL MASK; Generic name: MASK, SURGICAL; Manufacturer: TRAVERSE BAY MANUFACTURING.
| Device | SURGICAL MASK |
|---|---|
| Generic name | MASK, SURGICAL |
| Manufacturer | TRAVERSE BAY MANUFACTURING |
| Report number | MW5094263 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-24 |
| Narrative | TRAVERSE BAY MANUFACTURING IN (B)(6) IS SELLING FAULTY SURGICAL MASKS. THEY CLAIM "THE MATERIALS MEET AAMI PB 70 LEVEL IV STANDARDS. (THE HIGHEST VIRAL BARRIER LEVEL FOR A BREATHABLE MATERIAL)". AAMI LEVEL IV IS FOR SURGICAL GOWNS, NOT MASKS. THE NURSING HOME I WORK IN BOUGHT THESE MASKS FOR THE STAFF. THESE MASKS PROVIDE NO FILTRATION OF BACTERIA OR VIRUSES. THE DIFFERENTIAL PRESSURE (DELTA P) IS |
| Source | openFDA MAUDE (device adverse events) |
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