MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-12-07 for CHEST PAD COVERS 5844-13 manufactured by Mizuho Osi.
[2331455]
The distributor has notified mizuho osi that during use of the 5844-13 pad cover, a pt had an allergic reaction.
Patient Sequence No: 1, Text Type: D, B5
[9596617]
We have requested add'l info from the distributor, and will advise upon receipt (12/5/2011).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2011-00033 |
| MDR Report Key | 2398497 |
| Report Source | 08 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-12-05 |
| Date Mfgr Received | 2011-11-24 |
| Date Added to Maude | 2012-01-09 |
| 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 AVE. |
| Manufacturer City | UNION CITY CA 94587 |
| Manufacturer Country | US |
| Manufacturer Postal | 94587 |
| Manufacturer Phone | 5104768128 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHEST PAD COVERS |
| Generic Name | DISPOSABLE BEDDING |
| Product Code | KME |
| Date Received | 2011-12-07 |
| Model Number | 5844-13 |
| Catalog Number | 5844-13 |
| Device Availability | N |
| 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 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-07 |