MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-09 for ADVANCED CONTROL MODULAR BASE 5803 * manufactured by Osi/mizuho.
[17445703]
The patient was in prone position for 14 hour spine surgery on the jackson osi table. Extra padding placed around bony prominences. The patient was positioned by surgeon and operating room (or) staff. After surgery, the patient sustained serious deep tissue injury in 11 locations on the body, including across the anterior chest/torso, bilateral thigh and groin areas, bilateral shins, and heels.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921432 |
| MDR Report Key | 2921432 |
| Date Received | 2013-01-09 |
| Date of Report | 2013-01-09 |
| Date of Event | 2012-12-24 |
| Report Date | 2013-01-09 |
| Date Reported to FDA | 2013-01-09 |
| Date Added to Maude | 2013-01-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | ADVANCED CONTROL MODULAR BASE |
| Generic Name | TABLE, SURGICAL |
| Product Code | BWN |
| Date Received | 2013-01-09 |
| Model Number | 5803 |
| Catalog Number | * |
| Lot Number | 4957 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSI/MIZUHO |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-01-09 |