MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-12 for FLEXAM? NITRILE POWDER-FREE STERILE EXAM GLOVE * N8830 manufactured by Cardinal Health.
[21047704]
The pharmacy department was using these gloves. When they opened three boxes of these gloves, the gloves have a strange odor, were discolored, and made their hands itch. What was the original intended procedure? Wearing gloves for pharmacy use. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3189971 |
| MDR Report Key | 3189971 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-03-04 |
| Date of Event | 2013-02-07 |
| Report Date | 2013-03-04 |
| Date Reported to FDA | 2013-06-12 |
| Date Reported to Mfgr | 2013-06-26 |
| Date Added to Maude | 2013-06-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXAM? NITRILE POWDER-FREE STERILE EXAM GLOVE |
| Generic Name | POWDER FREE LATEX SURGEON'S GLOVES |
| Product Code | LYY |
| Date Received | 2013-06-12 |
| Model Number | * |
| Catalog Number | N8830 |
| Lot Number | 4W12J502 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN ROAD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-12 |