MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-20 for DUO FLEX FLUID CART N/A UL-DU500 manufactured by Dornoch.
[28950853]
The device investigation was not completed at the time of this report. A follow up medwatch will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[28950854]
It was reported that during surgery the duo flex fluid cart tubing sprayed onto the sterile field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001954182-2015-00001 |
| MDR Report Key | 5163406 |
| Date Received | 2015-10-20 |
| Date of Report | 2015-10-05 |
| Date of Event | 2015-10-05 |
| Date Mfgr Received | 2015-10-05 |
| Date Added to Maude | 2015-10-20 |
| 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 | JENNIFER HUTCHISON |
| Manufacturer Street | 200 NORTHWEST PARKWAY |
| Manufacturer City | RIVERSIDE MO 64150 |
| Manufacturer Country | US |
| Manufacturer Postal | 64150 |
| Manufacturer Phone | 8165052226 |
| Manufacturer G1 | DORNOCH |
| Manufacturer Street | 200 NORTHWEST PARKWAY |
| Manufacturer City | RIVERSIDE MO 64150 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64150 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DUO FLEX FLUID CART |
| Generic Name | DUO FLEX FLUID CART |
| Product Code | FLH |
| Date Received | 2015-10-20 |
| Model Number | N/A |
| Catalog Number | UL-DU500 |
| Lot Number | NA |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNOCH |
| Manufacturer Address | 200 NORTHWEST PARKWAY RIVERSIDE MO 64150 US 64150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-20 |