MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-11-13 for SMS ISOLATION GOWN-YELLOW manufactured by .
[15099149]
Sb, pt care tech, donned a yellow barrier gown for first time since this facilities conversion to this product. Within 15 to 20 minutes he noticed that his arms and neck where the skin was in contact with the gown began to feel very warm and itchy. He states he could see thru the gown that his skin was "beet red. " he then noticed that his eyes felt swollen. He removed the gown, notified the rn and came to clinic mgr's office. He had marked erythema of his face, neck and arms and his eyelids were swollen and nearly shut. His skin felt cold to touch, but was dripping wet. He denies sob, but said he felt very anxious. 911 was called; while awaiting their arrival he took oral benadryl and washed all skin area which had contacted gown. Symptoms began to subside rapidly and when squad arrived no treatment was given. He reported the next day that he took benadryl again that night and skin was still slightly reddened and a little itchy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2894706 |
| MDR Report Key | 2894706 |
| Report Source | 99 |
| Date Received | 2008-11-13 |
| Date of Report | 2008-11-04 |
| Date of Event | 2008-11-03 |
| Date Added to Maude | 2013-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMS ISOLATION GOWN-YELLOW |
| Generic Name | NONE |
| Product Code | OEA |
| Date Received | 2008-11-13 |
| Lot Number | 5743-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-11-13 |