Brand Name | FLUSHING PUMP OFP-2 (ROW) |
Type of Device | OLYMPUS FLUSHING PUMP |
Manufacturer (Section D) |
KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. |
keymed house, stock road |
southend on sea, essex SS25Q H |
UK SS25QH |
|
Manufacturer (Section G) |
KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. |
keymed house, stock road |
|
southend on sea, essex SS25Q H |
UK
SS25QH
|
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 18816735 |
MDR Text Key | 337312524 |
Report Number | 9611174-2024-01018 |
Device Sequence Number | 1 |
Product Code |
FEQ
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K100899 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/01/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/01/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | K10001145 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/02/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Treatment | GIF-Q260J |
|
|