MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-30 for ANORA ANORA FRESH manufactured by Natera.
[98781969]
Upon opening the anora, natera, single nucleotide polymorphism (snp) microassay chromosome analysis collection kit in the operating room, it was discovered that the specimen container did not contain any solution. A subsequent kit was opened to acquire the needed solution. The involved test kit was utilized on friday (b)(6) 2018 and subsequently mailed for processing. Add'l info available from the (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074986 |
| MDR Report Key | 7230584 |
| Date Received | 2018-01-30 |
| Date of Report | 2018-01-29 |
| Date of Event | 2018-01-26 |
| Date Added to Maude | 2018-01-31 |
| 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 | ANORA |
| Generic Name | MISCARRIAGE TEST KIT |
| Product Code | KIQ |
| Date Received | 2018-01-30 |
| Model Number | ANORA FRESH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATERA |
| Manufacturer Address | AUSTIN TX 78753 US 78753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-30 |