Brand Name | FLUSHING PUMP OFP-2 (US) |
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 |
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 17892801 |
MDR Text Key | 325172722 |
Report Number | 9611174-2023-00044 |
Device Sequence Number | 1 |
Product Code |
FEQ
|
UDI-Device Identifier | 15019778003191 |
UDI-Public | 15019778003191 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/08/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/09/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | K10001141 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/03/2023 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/21/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/20/2023 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|