MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-03-16 for 6977 AXIS JACKSON TABLE manufactured by Mizuho Orthopedic Systems, Inc..
[1857403]
Customer concerned with tables bilateral chest pad used for prone positioning as when table is tilted pts are known to shift and with the one pt there was skin shearing. Surgery was for approx 6 hours and it was noted that the pt developed redness and bruising on the inside of her right breast.
Patient Sequence No: 1, Text Type: D, B5
[9114630]
Initial evaluation will advise upon receipt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2011-00007 |
| MDR Report Key | 2061033 |
| Report Source | 05,06,07 |
| Date Received | 2011-03-16 |
| Date of Report | 2011-03-15 |
| Date of Event | 2011-02-16 |
| Date Mfgr Received | 2011-03-04 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768128 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6977 AXIS JACKSON TABLE |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | JEB |
| Date Received | 2011-03-16 |
| Model Number | 6977 |
| Catalog Number | 6977 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-16 |