MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-12 for FLYTE HELMET 0408600000 manufactured by Stryker Instruments-kalamazoo.
[30983098]
It was reported that during testing conducted at the user facility the device was overheating. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[32603726]
The device was tested and no failures were found. The device was scrapped.
Patient Sequence No: 1, Text Type: N, H10
[32603727]
It was reported that during testing conducted at the user facility the device was overheating. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-04115 |
| MDR Report Key | 5219804 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-11-12 |
| Date of Report | 2015-10-19 |
| Date of Event | 2015-10-19 |
| Date Mfgr Received | 2015-12-02 |
| Device Manufacturer Date | 2015-06-24 |
| Date Added to Maude | 2015-11-12 |
| 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 | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| 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 HELMET |
| Generic Name | HELMET, SURGICAL |
| Product Code | FXZ |
| Date Received | 2015-11-12 |
| Returned To Mfg | 2015-10-20 |
| Catalog Number | 0408600000 |
| Device Availability | R |
| Device Age | 3 MO |
| 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 | 2015-11-12 |