MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for FLUIDSHIELD 28800 manufactured by Om Halyard, Inc..
[142883946]
Seven respiratory therapists and a few nurses had adverse reactions to the halyard fluidshield masks. Some reactions resulted in asthma attacks one of which required an ec visit, while others resulted in a facial rash and hives. Reactions were so widespread and severe that we discontinued use of this particular product. Manufacturer response for fluid resistant protection mask, fluidshield level 3 fog-free procedure mask, wrap around visor, orage (per site reporter). These masks have been swapped for a different product number. We are closely monitoring the use of these masks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8543722 |
| MDR Report Key | 8543722 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-03-01 |
| Report Date | 2019-03-19 |
| Date Reported to FDA | 2019-03-19 |
| Date Reported to Mfgr | 2019-04-24 |
| Date Added to Maude | 2019-04-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2019-04-24 |
| Model Number | 28800 |
| Catalog Number | 28800 |
| Lot Number | AM8361041; POSSIBLY OTHERS |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OM HALYARD, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-24 |