Brand Name | VERSAFLEX |
Type of Device | ELECTRODE, PH, STOMACH |
Manufacturer (Section D) |
GIVEN IMAGING, INC. |
15 hampshire street |
mansfield MA 02048 |
|
MDR Report Key | 9362180 |
MDR Text Key | 167593886 |
Report Number | 9362180 |
Device Sequence Number | 1 |
Product Code |
FFT
|
UDI-Device Identifier | 04260167483740 |
UDI-Public | (01)04260167483740 |
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 |
11/13/2019,11/11/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/22/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 900003 |
Device Catalogue Number | 900003 |
Device Lot Number | F1919201UA |
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 | 11/13/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/22/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 17155 DA |
|
|