MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-02-04 for COMFORT HOOD 4380C manufactured by Cardinal Health.
[310565]
Hood caused one patient to break out in a severe rash all over their face. They had to go to the e. R. Customer alleges they broke out from the light blue hood (says 4380c-50).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2004-00009 |
| MDR Report Key | 509627 |
| Report Source | 05 |
| Date Received | 2004-02-04 |
| Date of Report | 2004-01-06 |
| Date Mfgr Received | 2004-01-23 |
| Device Manufacturer Date | 1975-04-01 |
| Date Added to Maude | 2004-02-05 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | SURGICAL GROUP EL PASO |
| Manufacturer Street | ONE BUTTERFIELD TRAIL |
| Manufacturer City | EL PASO TX 79906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORT HOOD |
| Generic Name | COMFORT HOOD |
| Product Code | FXY |
| Date Received | 2004-02-04 |
| Model Number | 4380C |
| Catalog Number | 4380C |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 498594 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | COMFORT HOOD |
| Baseline Generic Name | COMFORT HOOD |
| Baseline Model No | 4380C |
| Baseline Catalog No | 4380C |
| Baseline Device Family | APPAREL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-02-04 |