Brand Name | BRAVO |
Type of Device | ELECTRODE, PH, STOMACH |
Manufacturer (Section D) |
COVIDIEN LP |
15 hampshire street |
mansfield MA 02048 |
|
MDR Report Key | 13288664 |
MDR Text Key | 284011919 |
Report Number | 13288664 |
Device Sequence Number | 1 |
Product Code |
FFT
|
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 |
01/10/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/19/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | FGS-0636 |
Device Catalogue Number | FGS-0636 |
Device Lot Number | 54584F |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/10/2022 |
Date Report to Manufacturer | 01/19/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 18615 DA |
|
|