MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-09 for UROS MONITOR BK10001M manufactured by C.r. Bard, Inc. (covington) -1018233.
[74898046]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[74898047]
It was reported that while on a patient, the cartridge was attached, and was overwhelmed by retained urine. The urine began overflowing into the bag, and the monitor was not able to cycle fast enough to capture all of the retained urine. The monitor over reported and under reported the volume of urine multiple times throughout the duration of use. The monitor also began receiving a tilt alarm, although the device was reportedly level. The monitor remained on the patient for the duration it was needed.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1018233-2017-02312 |
MDR Report Key | 6555495 |
Date Received | 2017-05-09 |
Date of Report | 2017-10-05 |
Date Mfgr Received | 2017-09-19 |
Device Manufacturer Date | 2017-01-09 |
Date Added to Maude | 2017-05-09 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
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 |
Manufacturer Contact | AMY GRAVLEY |
Manufacturer Street | 8195 INDUSTRIAL BLVD |
Manufacturer City | COVINGTON GA 30014 |
Manufacturer Country | US |
Manufacturer Postal | 30014 |
Manufacturer Phone | 7707846100 |
Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
Manufacturer Street | 8195 INDUSTRIAL BLVD |
Manufacturer City | COVINGTON GA 30014 |
Manufacturer Country | US |
Manufacturer Postal Code | 30014 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | UROS MONITOR |
Generic Name | UROS MONITOR |
Product Code | EXS |
Date Received | 2017-05-09 |
Returned To Mfg | 2017-04-24 |
Model Number | BK10001M |
Catalog Number | BK10001M |
Lot Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-05-09 |