MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-24 for FLUIDSHIELD N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK 46867 manufactured by Halyard Health Inc..
[121501810]
Nurses taking care of (b)(6) patient. Went to use the halyard fluidshield* 3 n95 mask and the straps were rotted. No recoil and some even snapped. Only the small sizes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7901449 |
| MDR Report Key | 7901449 |
| Date Received | 2018-09-24 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-09-14 |
| Report Date | 2018-09-17 |
| Date Reported to FDA | 2018-09-17 |
| Date Reported to Mfgr | 2018-09-24 |
| Date Added to Maude | 2018-09-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUIDSHIELD N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2018-09-24 |
| Model Number | 46867 |
| Catalog Number | 46867 |
| Lot Number | AM7273811 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY 3RD FLOOR WEST ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-24 |