MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-14 for TRIFLEX LATEX SURGICAL GLOVES * 2D7257 manufactured by Cardinal Health.
[1612015]
Brought 2 pairs of triflex sterile gloves from or. When pulled to open, the packaging tore apart. Both from same lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1753939 |
| MDR Report Key | 1753939 |
| Date Received | 2010-06-14 |
| Date of Report | 2010-06-14 |
| Date of Event | 2010-06-08 |
| Report Date | 2010-06-14 |
| Date Reported to FDA | 2010-06-14 |
| Date Added to Maude | 2010-07-13 |
| 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 | 0 |
| 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 | TRIFLEX LATEX SURGICAL GLOVES |
| Generic Name | GLOVES |
| Product Code | OPE |
| Date Received | 2010-06-14 |
| Model Number | * |
| Catalog Number | 2D7257 |
| Lot Number | 11 TS08020452 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD. WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-14 |