MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-12 for ROM PLUS COMPLETE KIT ROM-8025 manufactured by Clinical Innovations.
[77627116]
Prior to use, the device was noted to not have the fluid inside the cassette. Fluid within the cassette should be present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070395 |
| MDR Report Key | 6639599 |
| Date Received | 2017-06-12 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-06-12 |
| Date Added to Maude | 2017-06-14 |
| 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 |
| 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 | 0 |
| Brand Name | ROM PLUS COMPLETE KIT |
| Generic Name | ROM PLUS COMPLETE KIT |
| Product Code | NQM |
| Date Received | 2017-06-12 |
| Model Number | ROM-8025 |
| Lot Number | 161660 |
| Device Expiration Date | 2019-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS |
| Manufacturer Address | MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-12 |