Brand Name | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE |
Type of Device | FER LIGATOR, HEMORRHOIDAL |
Manufacturer (Section D) |
COOK IRELAND LTD |
o halloran road |
limerick |
|
Manufacturer (Section G) |
COOK IRELAND LTD |
o halloran road |
national technology park |
limerick |
|
Manufacturer Contact |
heather
ryan
|
o halloran road |
national technology park |
limerick
|
061334440
|
|
MDR Report Key | 8205973 |
MDR Text Key | 131917034 |
Report Number | 3001845648-2018-00617 |
Device Sequence Number | 1 |
Product Code |
FER
|
Combination Product (y/n) | N |
PMA/PMN Number | K060623 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/28/2019 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 12/31/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 02/08/2019 |
Device Model Number | G34063 |
Device Catalogue Number | HMBL-4-TRI |
Device Lot Number | C1451178 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/27/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 12/31/2018 |
Event Location |
Hospital
|
Date Manufacturer Received | 11/20/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/08/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|