MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-08 for FLYTE LIGHTED HELMET BP 0408645000 manufactured by Stryker Instruments-kalamazoo.
[49029828]
The device was not returned for analysis.
Patient Sequence No: 1, Text Type: N, H10
[49029829]
It was reported that during a surgical procedure at the user facility the device heated up. It was reported that a loose thread from the surgical hood was entangled in the fan. There was no surgical delay, no medical intervention and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[49503014]
Patient Sequence No: 1, Text Type: N, H10
[49503015]
It was reported that during a surgical procedure at the user facility the device heated up. It was reported that a loose thread from the surgical hood was entangled in the fan. There was no surgical delay, no medical intervention and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2016-01089 |
| MDR Report Key | 5778172 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-08 |
| Date of Report | 2016-06-14 |
| Date of Event | 2016-06-10 |
| Date Mfgr Received | 2016-06-14 |
| Device Manufacturer Date | 2013-11-04 |
| Date Added to Maude | 2016-07-08 |
| 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 LIGHTED HELMET BP |
| Generic Name | HELMET, SURGICAL |
| Product Code | FXZ |
| Date Received | 2016-07-08 |
| Catalog Number | 0408645000 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-07-08 |