MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for SURESTEP manufactured by C.r. Bard, Inc..
[112477245]
The balloon detached from the foley and was retained in the bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7641549 |
| MDR Report Key | 7641549 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-05-25 |
| Report Date | 2018-06-11 |
| Date Reported to FDA | 2018-06-11 |
| Date Reported to Mfgr | 2018-06-27 |
| Date Added to Maude | 2018-06-27 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESTEP |
| Generic Name | CATHETER, INDWELLING URETHRAL |
| Product Code | FCN |
| Date Received | 2018-06-27 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-27 |