Brand Name | MED-DYNE |
Type of Device | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
Manufacturer (Section D) |
MED-DYNE, INC. |
2775 s. floyd st. |
louisville KY 40209 |
|
MDR Report Key | 14192305 |
MDR Text Key | 289958391 |
Report Number | 14192305 |
Device Sequence Number | 1 |
Product Code |
DSA
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
04/13/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/25/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | R24AS |
Device Catalogue Number | R24AS |
Device Lot Number | 022243896 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/13/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 04/25/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 30 DA |
Patient Sex | Male |
|
|