MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-06-25 for DUO FLEX FLUID CART SMOKE UL-DU500SE manufactured by Dornoch Medical.
[6043603]
It was reported from employee health at the user facility that a hospital staff member cut her finger while cleaning the duo flex fluid cart with smoke evacuator. It was stated that the individual cut her finger on the lip of the cl housing while wiping down the unit. The customer inquired about potential exposure. Despite multiple follow up attempts with the customer, no additional information was received prior to this report. If additional information is received, a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[13955995]
The device was installed on (b)(6) 2015 and has no repair history with zimmer. The device was not made available for evaluation or repair by zimmer. The customer's reported event could not be confirmed and a cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1954182-2015-00002 |
| MDR Report Key | 4874027 |
| Report Source | 06 |
| Date Received | 2015-06-25 |
| Date of Report | 2015-06-05 |
| Date of Event | 2015-06-05 |
| Date Mfgr Received | 2015-06-05 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2015-07-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHLEEN SMITH |
| Manufacturer Street | 200 NW PKWY. RD. |
| Manufacturer City | RIVERSIDE MO 64150 |
| Manufacturer Country | US |
| Manufacturer Postal | 64150 |
| Manufacturer Phone | 3303438801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUO FLEX FLUID CART SMOKE |
| Generic Name | DUO FLEX FLUID CART SMOKE |
| Product Code | FLH |
| Date Received | 2015-06-25 |
| Model Number | NA |
| Catalog Number | UL-DU500SE |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNOCH MEDICAL |
| Manufacturer Address | 200 NW PKWY RD. RIVERSIDE MO 64150 US 64150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-25 |