MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for AFINION 2 UNK manufactured by Abbott / Alere Technologies As.
[120965622]
I just received an afinion 2 system. At this time we are concerned that it is not compliant with udi standards. At this present time there is a serial number on the rating label, but there is no other unique identifiers such as gtin or saleable number. Gudid data might be hard to obtain with only this limited info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079899 |
| MDR Report Key | 7889533 |
| Date Received | 2018-09-18 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-09-07 |
| Date Added to Maude | 2018-09-19 |
| 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 | AFINION 2 |
| Generic Name | DENSITOMETER / SCANNER (INTEGRATING, REFLECTANCE, TLC |
| Product Code | JQT |
| Date Received | 2018-09-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT / ALERE TECHNOLOGIES AS |
| Manufacturer Address | 9975 SUMMERS RIDGE RD SAN DIAGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-18 |