MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-22 for DYK1002DCB manufactured by Medline Industries Inc..
Report Number | 1417592-2019-00106 |
MDR Report Key | 8811267 |
Date Received | 2019-07-22 |
Date of Report | 2019-07-22 |
Date of Event | 2019-07-01 |
Date Mfgr Received | 2019-07-01 |
Date Added to Maude | 2019-07-22 |
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 | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | NIGEL VILCHES |
Manufacturer Street | THREE LAKES DRIVE |
Manufacturer City | NORTHFIELD IL 600932753 |
Manufacturer Country | US |
Manufacturer Postal | 600932753 |
Manufacturer Phone | 2249311458 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Generic Name | BRUSH, CLEANING, DOUBLE ENDED, W/ HA |
Product Code | MNL |
Date Received | 2019-07-22 |
Catalog Number | DYK1002DCB |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDLINE INDUSTRIES INC. |
Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-07-22 |