Brand Name | CAPTURA |
Type of Device | DISLODGER, STONE, BASKET, URETERAL, METAL |
Manufacturer (Section D) |
COOK INCORPORATED |
750 daniels way |
bloomington IN 47404 |
|
MDR Report Key | 6593616 |
MDR Text Key | 76038618 |
Report Number | 6593616 |
Device Sequence Number | 1 |
Product Code |
FFL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/28/2017,05/08/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/26/2017 |
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 06/01/2018 |
Device Model Number | G32749 |
Device Catalogue Number | CE-532115 |
Device Lot Number | 5998934 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/28/2017 |
Device Age | 1 DY |
Event Location |
Hospital
|
Date Report to Manufacturer | 04/28/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 63 YR |
|
|