MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-01 for EXIDINE * 4489 manufactured by Carefusion.
[3824195]
The solution was found leaking within the packaging prior to use. What was the original intended procedure? Unknown. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3273391 |
| MDR Report Key | 3273391 |
| Date Received | 2013-08-01 |
| Date of Report | 2013-08-01 |
| Date of Event | 2013-05-23 |
| Report Date | 2013-08-01 |
| Date Reported to FDA | 2013-08-01 |
| Date Reported to Mfgr | 2013-08-09 |
| Date Added to Maude | 2013-08-09 |
| 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 | EXIDINE |
| Generic Name | SKIN PREP TRAY |
| Product Code | OJU |
| Date Received | 2013-08-01 |
| Model Number | * |
| Catalog Number | 4489 |
| Lot Number | 0000536006 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 10020 PACIFIC MESA BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-01 | |
| 2 | 0 | 2013-08-01 |