MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-25 for MEDLINE 3G VINYL GLOVES CUR 8326 manufactured by Medline Industries Inc..
[21612452]
After wearing 3g curad vinyl gloves, hands became red, extremely dry and formed sores that opened and were bleeding. Dates of use: (b) (6) 2010 - (b) (6) 2010. Diagnosis or reason for use: ppe for resident care. Event abated after use stopped or does reducted? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015320 |
| MDR Report Key | 1647160 |
| Date Received | 2010-03-25 |
| Date of Report | 2010-03-25 |
| Date of Event | 2010-03-20 |
| Date Added to Maude | 2010-04-05 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE 3G VINYL GLOVES |
| Generic Name | VINYL GLOVES |
| Product Code | OPF |
| Date Received | 2010-03-25 |
| Model Number | CUR 8326 |
| Lot Number | MA904546686 |
| ID Number | REFCUR8236 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-25 |