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 2010-12-16 for JACKSON SPINAL TABLE SYSTEM manufactured by Mizuho Osi.
[1780294]
The nurse manager at (b)(6) hospital has contacted mizuho osi concerning patients having skin tears. The patients were obese with large abdomens and difficult to position. After the surgery, the patients were turned and showed signs of skin tears (going and chest regions). They wanted to know if there were options to control this issue (in-service, add'l pads, etc. ).
Patient Sequence No: 1, Text Type: D, B5
[8943697]
Our initial investigation has found the customer to not using the covers on the pads for surgery and sent some patient kits for the hospital to trial ((b)(6) 2010). At that time of contact, we also reviewed the table and requested a preventative maintenance as the table's armboards were stuck in position with unk debris. Since the incident our sales rep has tried to contact the hospital but has not received a response.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2010-00017 |
| MDR Report Key | 1961619 |
| Report Source | 05,06,07 |
| Date Received | 2010-12-16 |
| Date of Report | 2010-12-14 |
| Date Mfgr Received | 2010-11-15 |
| Date Added to Maude | 2011-04-06 |
| 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 | 5104768126 |
| Manufacturer G1 | MIZUHO OSI |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 94587123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 1234 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JACKSON SPINAL TABLE SYSTEM |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | JEB |
| Date Received | 2010-12-16 |
| 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 OSI |
| Manufacturer Address | 30031 AHERN AVE. UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-16 |