MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-25 for SKYTRON 3501C * manufactured by Mizuho.
[2733363]
In response to (b)(6) mdr# (b)(4). Device manufacture date: 11/2011. Skytron received the 3501c surgical table back from the (b)(6) on (b)(4) 2012. A comprehensive assessment and eval will be conducted and documented. Skytron is coordinating sending 2 reps to (b)(6) for further interviews and investigations. Additionally, we are returning the table to the mfr in (b)(4) for their thorough investigation and review. When we receive their report, skytron will resubmit a final mdr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2012-00007 |
| MDR Report Key | 2680697 |
| Date Received | 2012-07-25 |
| Date Facility Aware | 2012-07-16 |
| Report Date | 2012-07-25 |
| Date Reported to Mfgr | 2012-07-19 |
| Date Added to Maude | 2012-08-03 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | SURGICAL TABLE |
| Product Code | BWN |
| Date Received | 2012-07-25 |
| Model Number | 3501C |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 9 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO |
| Manufacturer Address | * TOKYI * JA * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-25 |