Brand Name | NGAGE NITINOL STONE EXTRACTOR |
Type of Device | FFL DISLODGER, STONE, BASKET, URETERAL, METAL |
Manufacturer (Section D) |
COOK INC |
750 daniels way |
bloomington IN 47404 |
|
Manufacturer (Section G) |
COOK INC |
750 daniels way |
|
bloomington IN 47404 |
|
Manufacturer Contact |
jason
crouch
|
750 daniels way |
bloomington, IN 47404
|
8123392235
|
|
MDR Report Key | 19203227 |
MDR Text Key | 341296168 |
Report Number | 1820334-2024-00582 |
Device Sequence Number | 1 |
Product Code |
FFL
|
UDI-Device Identifier | 10827002482941 |
UDI-Public | (01)10827002482941(17)260913(10)15653721 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/29/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/29/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | NGE-017115 |
Device Lot Number | 15653721 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/25/2024 |
Date Manufacturer Received | 04/07/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/13/2023 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 55 YR |
Patient Sex | Male |