MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-05-25 for FLYTE HOOD 0408800000 manufactured by Stryker Instruments Kalamazoo.
[2115119]
It was reported that a cotton lint ball came out of the helmet and fell onto the surgical table. There was no indication that anything entered the surgical site. There were no allegations of adverse consequences associated with this event. The procedure was successfully completed as planned.
Patient Sequence No: 1, Text Type: D, B5
[9155907]
The device has not yet been returned to the mfr for eval. A quality investigation will be performed when the product is received and a f/u report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2011-01903 |
| MDR Report Key | 2137538 |
| Report Source | 01,07 |
| Date Received | 2011-05-25 |
| Date of Report | 2011-04-28 |
| Date of Event | 2011-04-28 |
| Date Mfgr Received | 2011-04-28 |
| Device Manufacturer Date | 2009-01-30 |
| Date Added to Maude | 2011-08-10 |
| 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 | CHRISTINA MCKEE |
| 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 | 2011-05-25 |
| Catalog Number | 0408800000 |
| Lot Number | 0903064 |
| Device Expiration Date | 2012-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-05-25 |