Brand Name | AVETA FLEX DISPOSABLE RESECTING DEVICE, 2.9 MM |
Type of Device | INSUFFLATOR, HYSTEROSCOPIC |
Manufacturer (Section D) |
MEDITRINA, INC. |
1190 saratoga ave, suite 180 |
san jose CA 95129 |
|
MDR Report Key | 18282458 |
MDR Text Key | 329938809 |
Report Number | 18282458 |
Device Sequence Number | 1 |
Product Code |
HIG
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/13/2023 |
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 Model Number | 210-080 |
Device Catalogue Number | 210-080 |
Device Lot Number | F22D28-02 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/13/2023 |
Event Location |
Hospital
|
Date Report to Manufacturer | 12/07/2023 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/07/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|