MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2008-04-04 for ADVANCED CONTROL PAD SYSTEM 5943API manufactured by Mizuho Orthopedic Systems, Inc..
[812419]
After a three hr surgery, the pt's skin was breaking down.
Patient Sequence No: 1, Text Type: D, B5
[8025369]
Investigation found the end-user inappropriately positioning the placement and using the wrong size pads. They were also inappropriately positioning the pt on the pads and table. It was also determined that the hospital was not using the pt care kit to reduce abrasions and stiction of the pt on the pads. An inservice with the hosp has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2008-00008 |
| MDR Report Key | 1025911 |
| Report Source | 01 |
| Date Received | 2008-04-04 |
| Date of Report | 2008-03-01 |
| Date of Event | 2008-03-04 |
| Date Mfgr Received | 2008-03-06 |
| Date Added to Maude | 2008-08-29 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 94587123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 1234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED CONTROL PAD SYSTEM |
| Generic Name | MODULAR OPERATING ROOM TABLE SYSTEM |
| Product Code | FWY |
| Date Received | 2008-04-04 |
| Model Number | 5943API |
| Catalog Number | 5943API |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1024341 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE. UNION CITY CA 945871234 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5803 | 1. Other | 2008-04-04 |