MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-04-02 for SKYTRON UNKNOWN manufactured by Mizuho.
[16376141]
(b)(4)'s distributor in the area, (b)(4) is returning the table to (b)(4) for examination. We will then send the table to the manufacturer in (b)(4) for their final conclusion and will report back to fda when we have their report. The facility has been given a loaner table to use in the meantime.
Patient Sequence No: 1, Text Type: N, H10
[16682856]
In response to (b)(6), mdr # (b)(4) received on (b)(4) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2013-00004 |
| MDR Report Key | 3267270 |
| Report Source | 99 |
| Date Received | 2013-04-02 |
| Date Facility Aware | 2013-03-18 |
| Report Date | 2013-04-02 |
| Date Added to Maude | 2013-08-08 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2-27-17 HONGO, BUNKYO-KU ICN BLDG., 5F |
| Manufacturer City | TOKYO 113-0033 |
| Manufacturer Country | JA |
| Manufacturer Postal | 113-0033 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | SURGICAL TABLE |
| Product Code | LGX |
| Date Received | 2013-04-02 |
| Model Number | UNKNOWN |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-02 |