Brand Name | MEDICHOICE ULTRASOUND GEL |
Type of Device | TRANSDUCER, ULTRASONIC, DIAGNOSTIC |
Manufacturer (Section D) |
ECO-MED PHARMACEUTICALS, INC. |
|
|
MDR Report Key | 12343066 |
MDR Text Key | 267626941 |
Report Number | MW5103355 |
Device Sequence Number | 1 |
Product Code |
ITX
|
Combination Product (y/n) | Y |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Type of Report
| Initial |
Report Date |
08/17/2021 |
3 Devices were Involved in the Event: |
1
2
3
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 03/30/2024 |
Device Lot Number | B030 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/18/2021 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 55 YR |
Patient Weight | 62 |
|
|