MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-05-03 for GOWN, ISOLATION, IMPERVIOUS, YELLOW, XL, 7101PG manufactured by Cardinal Health.
[19952929]
Several nurses within the icu had rashes above gloves, below scrubs and around neck. Essentially any skin exposed to the gown materail. Cunstomer contact reports staff#1 went to the emergency room due to severe contact dermatitis. Staff#1 experience itcy, red, irritated skin. Received cortisone rx both intermally and externally. Stent home for remainder of worday. Staff#1 discontinued use of this particular grown without further incident. Staff memebers #2 and #3 disrobed and continued their work day and dutties without any type of medical rx, tx ir intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2006-00055 |
| MDR Report Key | 707886 |
| Report Source | 05,07 |
| Date Received | 2006-05-03 |
| Date of Report | 2006-05-03 |
| Date of Event | 2006-03-20 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2006-05-05 |
| 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 | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD, BLDG KB |
| Manufacturer City | MCGRAW PARK IL 66085 |
| Manufacturer Country | US |
| Manufacturer Postal | 66085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | EL PASO - CONVERTORS |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOWN, ISOLATION, IMPERVIOUS, YELLOW, XL, |
| Generic Name | GOWN, ISOLATION, IMPERVIOUS, YELLOW, XL, |
| Product Code | FYC |
| Date Received | 2006-05-03 |
| Model Number | 7101PG |
| Catalog Number | 7101PG |
| Lot Number | 05LAK3023 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 696937 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Baseline Brand Name | GOWN, ISOLATION, IMPERVIOUS, YELLOW, XL, |
| Baseline Generic Name | GOWN, ISOLATION, IMPERVIOUS, YELLOW, XL, |
| Baseline Model No | 7101PG |
| Baseline Catalog No | 7101PG |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-05-03 |