Brand Name | ALIMAXX-ED |
Type of Device | PROSTHESIS, ESOPHAGEAL |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
1600 west merit parkway |
south jordan UT 84095 |
|
MDR Report Key | 17070271 |
MDR Text Key | 316585326 |
Report Number | 17070271 |
Device Sequence Number | 1 |
Product Code |
ESW
|
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 |
05/30/2023,05/25/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 00884450030646 |
Device Catalogue Number | 80129-202/C |
Device Lot Number | MR2258732 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 05/30/2023 |
Event Location |
Hospital
|
Date Report to Manufacturer | 06/06/2023 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/06/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 23725 DA |
Patient Sex | Female |
Patient Weight | 63 KG |
Patient Race | White |
|
|