Brand Name | RED MEDICAL SUPPLIES ULTRASOUND GEL |
Type of Device | TRANSDUCER, ULTRASONIC, DIAGNOSTIC |
Manufacturer (Section D) |
ECO-MED PHARMACEUTICALS, INC. |
|
|
MDR Report Key | 12306946 |
MDR Text Key | 266206175 |
Report Number | MW5103139 |
Device Sequence Number | 1 |
Product Code |
ITX
|
Combination Product (y/n) | Y |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/06/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/25/2024 |
Device Lot Number | B072 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/10/2021 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
|
Patient Age | 37 YR |
Patient Weight | 77 |
|
|