MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-12-11 for STERI-SHIELD HOOD 0400-800-000 N/ manufactured by Stryker Instruments.
[211343]
Hospital alleges three nurses experienced facial rashes caused by the sweatband in the device. No add'l treatment was given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1811755-2001-00034 |
| MDR Report Key | 366314 |
| Report Source | 06 |
| Date Received | 2001-12-11 |
| Date of Report | 2001-12-11 |
| Date of Event | 2001-11-07 |
| Date Facility Aware | 2001-11-07 |
| Report Date | 2001-12-11 |
| Date Mfgr Received | 2001-12-11 |
| Date Added to Maude | 2001-12-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 4100 E MILHAM AVE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 6163237700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERI-SHIELD HOOD |
| Generic Name | HOOD, SURGICAL |
| Product Code | FXY |
| Date Received | 2001-12-11 |
| Model Number | 0400-800-000 |
| Catalog Number | N/ |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 355437 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 E MILHAM AVE KALAMAZOO MI 49001 US |
| Baseline Brand Name | STERI-SHIELD HOOD |
| Baseline Generic Name | HOOD, SURGICAL |
| Baseline Model No | 0400-800-000 |
| Baseline Catalog No | N/ |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-12-11 |