MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for FLYTE SURGICOOL HOOD, PEELAWAY 0408801500 manufactured by Stryker Instruments-kalamazoo.
[143080615]
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 2? Events were reported for this quarter. Product return status; 1 device was not available for evaluation. 1 device investigation type has not yet been determined. ? Dditional information: 2? Devices were labeled for single-use. 2 devices were not reprocessed and reused.
Patient Sequence No: 1, Text Type: N, H10
[143080616]
This report summarizes 2 malfunction events in which the material integrity of the device was reportedly compromised. 2 events had patient involvement; no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2019-01506 |
| MDR Report Key | 8546488 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-07-26 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-01-01 |
| Date Added to Maude | 2019-04-24 |
| 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. ZACH BAKER |
| 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 | 0 |
| Brand Name | FLYTE SURGICOOL HOOD, PEELAWAY |
| Generic Name | HOOD, SURGICAL |
| Product Code | FXY |
| Date Received | 2019-04-24 |
| Catalog Number | 0408801500 |
| Device Availability | N |
| 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 | 2019-04-24 |