MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-02 for FLYTE HOOD W/PEELAWAY 0408800100 manufactured by Stryker Instruments Kalamazoo.
[3013401]
The flyte hood was sent for evaluation due to an unknown substance falling off of the hood and into the surgical site and sterile fields during a procedure. The procedure was completed with the same equipment without any procedure delay. No adverse event was associated with the device. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[10275512]
The device was received for evaluation; additional information will be submitted once the quality investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2012-03710 |
| MDR Report Key | 2783965 |
| Report Source | 05 |
| Date Received | 2012-10-02 |
| Date of Report | 2012-09-05 |
| Date of Event | 2012-09-05 |
| Date Mfgr Received | 2012-09-05 |
| Device Manufacturer Date | 2012-02-19 |
| Date Added to Maude | 2013-01-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHELSEA CULLEN |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| 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 HOOD W/PEELAWAY |
| Product Code | FXY |
| Date Received | 2012-10-02 |
| Returned To Mfg | 2012-09-25 |
| Catalog Number | 0408800100 |
| Lot Number | 12050580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-02 |