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 5844-12, PAD COVER manufactured by Mizuho Osi.
[2456312]
During the use of a pt care kit, the pt was found to have an allergic reaction where the kit touched the skin. The pt was given antihistamines and the allergic reaction subsided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2011-00034 |
| MDR Report Key | 2401751 |
| Report Source | 08 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-12-05 |
| Date of Event | 2011-11-14 |
| Date Mfgr Received | 2011-11-30 |
| Date Added to Maude | 2012-07-23 |
| 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 94587 |
| Manufacturer Country | US |
| Manufacturer Postal | 94587 |
| Manufacturer Phone | 5104768128 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5844-12, PAD COVER |
| Generic Name | BEDDING, DISPOSABLE |
| Product Code | KME |
| Date Received | 2011-12-07 |
| Model Number | 5844-12 |
| Catalog Number | 5844-12 |
| 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 | 1. Other | 2011-12-07 |