MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-15 for ROM + COMPLETE KIT ROM-5025 manufactured by Clinical Innovations, Llc.
| Report Number | MW5088156 |
| MDR Report Key | 8793899 |
| Date Received | 2019-07-15 |
| Date of Report | 2019-07-12 |
| Date of Event | 2019-07-10 |
| Date Added to Maude | 2019-07-16 |
| 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 | 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 | 0 |
| Brand Name | ROM + COMPLETE KIT |
| Generic Name | IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S) |
| Product Code | NQM |
| Date Received | 2019-07-15 |
| Model Number | ROM-5025 |
| Lot Number | 190318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS, LLC |
| Manufacturer Address | MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-15 |