MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-07 for KIT, CATHETER, FOLEY manufactured by C.r. Bard.
[79270095]
Patient Sequence No: 1, Text Type: N, H10
[79270096]
Hole noted in back of foley bag where the circle indents are located. The spine was bent and inside of the "racetrack". The bag was changed, but unable to change catheter as they were doing a ventriculostomy clamp trial and icp's did not allow for a change.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6692704 |
| MDR Report Key | 6692704 |
| Date Received | 2017-07-07 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-06-11 |
| Report Date | 2017-06-15 |
| Date Reported to FDA | 2017-06-15 |
| Date Reported to Mfgr | 2017-06-15 |
| Date Added to Maude | 2017-07-07 |
| 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 |
| 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 |
| Generic Name | KIT, CATHETER, FOLEY |
| Product Code | NWR |
| Date Received | 2017-07-07 |
| ID Number | 16 OR 18 FR TEMP SENSING |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD |
| Manufacturer Address | 1211 MARY MAGNAN BLVD. MADISON GA 30650 US 30650 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-07 |