Brand Name | COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER |
Type of Device | HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES) |
Manufacturer (Section D) |
COOK INC |
750 daniels way |
bloomington IN 47404 |
|
Manufacturer (Section G) |
COOK INC |
750 daniels way |
|
bloomington IN 47404 |
|
Manufacturer Contact |
larry
pool
|
750 daniels way |
bloomington, IN 47404
|
8128294891
|
|
MDR Report Key | 8133517 |
MDR Text Key | 129483887 |
Report Number | 1820334-2018-03634 |
Device Sequence Number | 1 |
Product Code |
HES
|
UDI-Device Identifier | 00827002174719 |
UDI-Public | (01)00827002174719(17)190224(10)6760122 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/05/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/05/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/24/2019 |
Device Catalogue Number | J-CHSG-703001 |
Device Lot Number | 6760122 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 11/29/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/24/2016 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |