MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for ROM PLUS COMPLETE KIT ROM-5025 manufactured by Clinical Innovations Europe, Ltd..
[122630056]
Rom plus complete kit, not enough liquid in the vial. Original kit discarded, new one obtained, no negative impact to patient. Original packaging available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080250 |
| MDR Report Key | 7925985 |
| Date Received | 2018-10-01 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-07-29 |
| Date Added to Maude | 2018-10-02 |
| 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 | IMMUNOASSAY FOR DETENTION OF AMNIOTIC FLUID PROTEIN(S) |
| Product Code | NQM |
| Date Received | 2018-10-01 |
| Model Number | ROM-5025 |
| Lot Number | 180484 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS EUROPE, LTD. |
| Manufacturer Address | HEATHROW UB111FW UK UB11 1FW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-01 |