MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-01 for STRYKER FLYTE HOOD 0408-801-400 manufactured by Stryker Corp.
[135744984]
Two employees reported burns on their face after wearing stryker flyte hoods in surgical case using uv lights.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083660 |
| MDR Report Key | 8301359 |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-07 |
| Date Added to Maude | 2019-02-04 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | STRYKER FLYTE HOOD |
| Generic Name | HOOD, SURGICAL |
| Product Code | FXY |
| Date Received | 2019-02-01 |
| Catalog Number | 0408-801-400 |
| Lot Number | 18061558 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP |
| Brand Name | STRYKER FLYTE HOOD |
| Generic Name | HOOD, SURGICAL |
| Product Code | FXY |
| Date Received | 2019-02-01 |
| Catalog Number | 0408-801-400 |
| Lot Number | 18061643 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |