MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-11 for FLYTE BATTERY POWERED LIGHTED HELMET 0408645000 manufactured by Stryker Instruments-kalamazoo.
[64431089]
It was reported that during a surgical procedure at the user facility the device over heated. The physician was able to complete the procedure. There was no surgical delay, no medical intervention and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[115066520]
Patient Sequence No: 1, Text Type: N, H10
[115066521]
It was reported that during a surgical procedure at the user facility the device over heated. The physician was able to complete the procedure. There was no surgical delay, no medical intervention and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2017-00037 |
| MDR Report Key | 6240338 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-11 |
| Date of Report | 2017-07-31 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2015-07-21 |
| Date Added to Maude | 2017-01-11 |
| 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 | MR. CASEY METZGER |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL MI NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLYTE BATTERY POWERED LIGHTED HELMET |
| Generic Name | HELMET, SURGICAL |
| Product Code | FXZ |
| Date Received | 2017-01-11 |
| Returned To Mfg | 2017-02-21 |
| Catalog Number | 0408645000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-11 |