MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-06 for FLYTE HOOD 0408800000 manufactured by Stryker Instruments Kalamazoo.
[3371952]
It was reported that prior to a surgical procedure at the user facility, a black hair was found inside the package of the hood. A back-up product was used to perform the procedure. No pt involvement, no delay, no medical intervention and no adverse consequences were alleged with this event.
Patient Sequence No: 1, Text Type: D, B5
[10389550]
Failure analysis is in progress; add'l info will be submitted once the quality investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2012-04231 |
| MDR Report Key | 2913937 |
| Report Source | 06 |
| Date Received | 2012-12-06 |
| Date of Report | 2012-11-18 |
| Date of Event | 2012-11-19 |
| Date Mfgr Received | 2012-11-18 |
| Device Manufacturer Date | 2012-04-10 |
| Date Added to Maude | 2013-02-22 |
| 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 | CORINNE LARKE |
| 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 |
| Product Code | FXY |
| Date Received | 2012-12-06 |
| Returned To Mfg | 2012-11-27 |
| Catalog Number | 0408800000 |
| Lot Number | 1210619 |
| 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 | 2012-12-06 |