MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for CORIS MD-02 manufactured by One Diversified, Llc.
[184826508]
On 02/05/2020, it was reported by a user facility that a medical device system installed in the operating suite, is potentially contributing to an increase in post-surgery infection rate due to the device location within the suite. The facility reported that infectious control conducted an investigation. The investigation revealed dust particles with the enclosure of the device system installed within the operating suites. Samples of the dust was analyzed by the facility and revealed similarities as the infections seen in pts. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093872 |
| MDR Report Key | 9865219 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-05 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CORIS |
| Generic Name | SYSTEM, DIGITAL IMAGE COMMUNICATIONS, RADIOLOGICAL |
| Product Code | LMD |
| Date Received | 2020-03-20 |
| Catalog Number | MD-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ONE DIVERSIFIED, LLC |
| Manufacturer Address | DALLAS TX 75229 US 75229 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |