MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-09-06 for 6977 manufactured by Mizuho Osi.
[16535052]
Pts are experiencing pressure ulcers on the skin that is touching the acp chest pad.
Patient Sequence No: 1, Text Type: D, B5
[16571414]
Initial registration of complaint, will advise after communication with hospital in (b)(4) and the distributor ((b)(4) 2011).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2011-00027 |
| MDR Report Key | 2244780 |
| Report Source | 06,07 |
| Date Received | 2011-09-06 |
| Date of Report | 2011-09-05 |
| Date Mfgr Received | 2011-08-25 |
| Date Added to Maude | 2012-06-28 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768128 |
| Manufacturer G1 | MIZUHO OSI |
| Manufacturer Street | 30031 AHERN AVENUE |
| 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 | 6977 |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | JEB |
| Date Received | 2011-09-06 |
| Model Number | 6977 |
| Catalog Number | 6977 |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO OSI |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-06 |