MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for KENDALL 22855 manufactured by Cardinal Health, Inc..
Report Number | 9180806 |
MDR Report Key | 9180806 |
Date Received | 2019-10-11 |
Date of Report | 2019-09-24 |
Date of Event | 2019-09-23 |
Report Date | 2019-09-24 |
Date Reported to FDA | 2019-09-24 |
Date Reported to Mfgr | 2019-10-10 |
Date Added to Maude | 2019-10-11 |
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 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | KENDALL |
Generic Name | ELECTRODE, ELECTROCARDIOGRAPH |
Product Code | DRX |
Date Received | 2019-10-11 |
Model Number | 22855 |
Catalog Number | 22855 |
Lot Number | 918950X |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CARDINAL HEALTH, INC. |
Manufacturer Address | 300 SOUTH RIVERSIDE PLAZA CHICAGO IL 60606 US 60606 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-10-11 |