MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-08-03 for HENRY SCHEIN ISOLATION GOWN 101-1789 manufactured by Xiantao Rayxin Medical.
[16323850]
The assistant alleges that she developed a rash on her right forearm, the left arm above her wrist up to her elbow and neck after wearing the gown. She had to seek medical attention with a dermatologist, who prescribed a steroid ointment, clobetasol 0. 05% for the dermatitis. The assistant is now avoiding polypropylene gowns and wearing cotton instead, as well as using the steroid ointment. Her symptoms of itching and redness have completely disappeared.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2012-00002 |
| MDR Report Key | 2687174 |
| Report Source | 99 |
| Date Received | 2012-08-03 |
| Date of Report | 2012-07-09 |
| Date of Event | 2012-05-04 |
| Date Facility Aware | 2012-07-09 |
| Report Date | 2012-08-02 |
| Date Reported to FDA | 2012-08-03 |
| Date Reported to Mfgr | 2012-08-02 |
| Date Added to Maude | 2012-08-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN ISOLATION GOWN |
| Generic Name | GOWN |
| Product Code | OEA |
| Date Received | 2012-08-03 |
| Catalog Number | 101-1789 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XIANTAO RAYXIN MEDICAL |
| Manufacturer Address | HUBEI PROVINCE CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-03 |