MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-07 for SURESTEP FOLEY TRAY SYSTEM * A800365 manufactured by Bard Medical.
| Report Number | 4686963 |
| MDR Report Key | 4686963 |
| Date Received | 2015-04-07 |
| Date of Report | 2015-04-07 |
| Date of Event | 2015-03-23 |
| Report Date | 2015-04-07 |
| Date Reported to FDA | 2015-04-07 |
| Date Reported to Mfgr | 2015-04-14 |
| Date Added to Maude | 2015-04-14 |
| 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 | SURESTEP FOLEY TRAY SYSTEM |
| Generic Name | KIT, FOLEY, CATHETER |
| Product Code | NWR |
| Date Received | 2015-04-07 |
| Model Number | * |
| Catalog Number | A800365 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD MEDICAL |
| Manufacturer Address | 1211 MARY MAGNAN BLVD. MADISON GA 30650 US 30650 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-07 |