MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-11-30 for FLYTE HOOD 0408800000 manufactured by Stryker Instruments Kalamazoo.
[19676114]
It was reported that lint was coming off the hood during a procedure. The account was concerned that some of the lint may have fallen into the surgical site. The surgical site was irrigated to remove the particles. No add'l treatment was given to the pt as a result of this event. There is no sign of infection at this time.
Patient Sequence No: 1, Text Type: D, B5
[19750000]
The device has been returned to the mfr for investigation. The investigation is ongoing. A follow up report will be filed when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2010-01841 |
| MDR Report Key | 1930484 |
| Report Source | 01,07 |
| Date Received | 2010-11-30 |
| Date of Report | 2010-11-05 |
| Date of Event | 2010-11-04 |
| Date Mfgr Received | 2010-11-05 |
| Device Manufacturer Date | 2009-01-30 |
| Date Added to Maude | 2011-02-08 |
| 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 | 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 |
| Generic Name | SURGICAL APPAREL |
| Product Code | FXY |
| Date Received | 2010-11-30 |
| Returned To Mfg | 2010-11-15 |
| Catalog Number | 0408800000 |
| Lot Number | 0903070 |
| Device Expiration Date | 2012-01-30 |
| 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 | 2010-11-30 |