Brand Name | DOPPLEX |
Type of Device | TRANSDUCER, ULTRASONIC, DIAGNOSTIC |
Manufacturer (Section D) |
HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS |
35 portmanmoor road |
splott |
cardiff, CF24 5HN |
UK CF24 5HN |
|
Manufacturer (Section G) |
HUNTLEIGH HEALTHCARE LTD |
35 portmanmoor road |
splott |
cardiff, CF24 5HN |
UK
CF24 5HN
|
|
Manufacturer Contact |
steve
monks
|
35 portmanmoor road |
splott |
cardiff, CF24 -5HN
|
UK
CF24 5HN
|
|
MDR Report Key | 13418038 |
MDR Text Key | 295785593 |
Report Number | 1000589001-2022-00001 |
Device Sequence Number | 1 |
Product Code |
ITX
|
UDI-Device Identifier | 05051968036544 |
UDI-Public | (01)05051968036544 |
Combination Product (y/n) | N |
Reporter Country Code | NL |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
505
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup |
Report Date |
09/21/2022 |
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 | DIOP8 |
Device Catalogue Number | DIPP10 |
Device Lot Number | 107842006001 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/27/2022 |
Initial Date Manufacturer Received |
01/21/2022
|
Initial Date FDA Received | 02/01/2022 |
Supplement Dates Manufacturer Received | 05/03/2022 01/20/2022
|
Supplement Dates FDA Received | 06/02/2022 09/21/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/23/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-0960-2022 |
Patient Sequence Number | 1 |
|
|