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 Contact |
larry
pool
|
750 daniels way |
bloomington, IN 47404
|
8123392235
|
|
MDR Report Key | 6720650 |
MDR Text Key | 80255755 |
Report Number | 1820334-2017-01596 |
Device Sequence Number | 1 |
Product Code |
FFL
|
UDI-Device Identifier | 00827002482944 |
UDI-Public | (01)00827002482944(17)200328(10)7783007 |
Combination Product (y/n) | N |
Reporter Country Code | CN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,user faci |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/11/2017 |
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 Model Number | N/A |
Device Catalogue Number | NGE-017115 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/20/2017 |
Initial Date FDA Received | 07/18/2017 |
Supplement Dates Manufacturer Received | 10/05/2017
|
Supplement Dates FDA Received | 10/11/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/28/2017 |
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 |
|
|