MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for DOVER P4P16TSD manufactured by Cardinal Health 200, Llc.
[114194394]
We have had three occurrences in the past 4 months where the covidien foley core temperature was lower than the oral temperature. In the latest occurrence, the temperature reading was 37. 7? C despite adequate urine output, and the oral thermometer reading was 39. 1? C. Manufacturer response for urine meter, covidien (per site reporter): representative has informed manager and filed a qa report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7693666 |
| MDR Report Key | 7693666 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-09 |
| Date of Event | 2018-07-07 |
| Report Date | 2018-07-09 |
| Date Reported to FDA | 2018-07-09 |
| Date Reported to Mfgr | 2018-07-17 |
| Date Added to Maude | 2018-07-17 |
| 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 | DOVER |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2018-07-17 |
| Model Number | P4P16TSD |
| Catalog Number | P4P16TSD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-17 |