MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-03-14 for FLYTE HOOD 0408800000 manufactured by Stryker Instruments Kalamazoo.
[15628619]
It was reported that fuzz from the hood was blown out of the helmet vents prior to the procedure. The account used a back up to complete the procedure with no allegation of adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[15849596]
The device was returned to the manufacturer for evaluation. Based on the quality investigation details, the white material on the top of the hoods was linting. A design change was implemented on (b)(4)-2010 to add a double scrim filter to the hoods and togas. This product was manufactured prior to this change.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2011-00801 |
| MDR Report Key | 2049976 |
| Report Source | 01,07 |
| Date Received | 2011-03-14 |
| Date of Report | 2011-02-16 |
| Date of Event | 2011-02-15 |
| Date Mfgr Received | 2011-02-16 |
| Device Manufacturer Date | 2009-02-09 |
| Date Added to Maude | 2011-06-10 |
| 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 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 | 3 |
| Brand Name | FLYTE HOOD |
| Generic Name | HOOD, SURGICAL |
| Product Code | FXY |
| Date Received | 2011-03-14 |
| Returned To Mfg | 2011-03-03 |
| Catalog Number | 0408800000 |
| Lot Number | 0904081 |
| Device Expiration Date | 2012-02-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-03-14 |