Brand Name | BRAVO CF CAPSULE |
Type of Device | ELECTRODE, PH, STOMACH |
Manufacturer (Section D) |
MEDTRONIC, INC. / COVIDIEN |
|
|
MDR Report Key | 11574609 |
MDR Text Key | 242826669 |
Report Number | MW5100295 |
Device Sequence Number | 1 |
Product Code |
FFT
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
03/24/2021 |
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 Expiration Date | 07/25/2022 |
Device Lot Number | 52091F |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/25/2021 |
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 Age | 51 YR |
Patient Weight | 58 |
|
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