MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-18 for ROM PLUS ROM-6025 manufactured by Clinical Innovations, Llc.
[89695743]
Patient Sequence No: 1, Text Type: N, H10
[89695744]
When collecting this patient's specimen, the rn noted that the buffer vial did not contain liquid buffer. The rn obtained another collection kit and collected the specimen and submitted it to the lab for testing. The rn examined the remaining collection kits and found 1 additional buffer vial that was empty. This was reported to the lab and they also found 1 of the same lot number with an empty buffer vial as well. Manufacturer response for rom plus collection device, (brand not provided) (per site reporter). Nothing at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6958282 |
| MDR Report Key | 6958282 |
| Date Received | 2017-10-18 |
| Date of Report | 2017-09-18 |
| Date of Event | 2017-09-10 |
| Report Date | 2017-09-18 |
| Date Reported to FDA | 2017-09-18 |
| Date Reported to Mfgr | 2017-09-18 |
| Date Added to Maude | 2017-10-18 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | PATIENT |
| 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 | ROM PLUS |
| Generic Name | IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S) |
| Product Code | NQM |
| Date Received | 2017-10-18 |
| Model Number | ROM-6025 |
| Lot Number | 170593 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS, LLC |
| Manufacturer Address | 747 W 4170 S MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-18 |