MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-21 for N/A manufactured by Mfr Unknown.
[83149693]
Patient Sequence No: 1, Text Type: N, H10
[83149694]
Bladder pressure monitoring device malfunction. Discovered that predetermined amount of ns instilled into bladder did not return/drain. Removed device from foley catheter and >300 ml drained from bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6807554 |
| MDR Report Key | 6807554 |
| Date Received | 2017-08-21 |
| Date of Report | 2017-08-15 |
| Date of Event | 2013-09-13 |
| Report Date | 2013-10-08 |
| Date Reported to FDA | 2013-10-08 |
| Date Reported to Mfgr | 2013-10-08 |
| Date Added to Maude | 2017-08-21 |
| 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 |
| Brand Name | N/A |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2017-08-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MFR UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-21 |