MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-12 for CONVERTORS YELLOW IMPERVIOUS ISOLATION GOWN W/KNIT CUFF, FULL BACK, UNIVERSAL REF 7100PG manufactured by Cardinal Health.
[17466352]
Two staff experienced skin and mucous irritation believed to be associated with a new disposable gown used for infectious isolation. Employees worn gowns for most of their 8 hour shifts after which they experienced their reaction. Both assessed at occupational medical services. Staff provided alternative gowns to wear for caring for patients on isolation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015946 |
| MDR Report Key | 1691092 |
| Date Received | 2010-05-12 |
| Date of Report | 2010-05-06 |
| Date of Event | 2010-05-05 |
| Date Added to Maude | 2010-05-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVERTORS YELLOW IMPERVIOUS ISOLATION GOWN W/KNIT CUFF, FULL BACK, UNIVERSAL |
| Generic Name | ISOLATION GOWN |
| Product Code | FYC |
| Date Received | 2010-05-12 |
| Catalog Number | REF 7100PG |
| Lot Number | 06C1N068 |
| Device Expiration Date | 2011-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-05-12 |