Brand Name | CARDIOCEL |
Type of Device | CARDIOVASCULAR PATCH |
Manufacturer (Section D) |
ADMEDUS REGEN PTY LTD |
26 harris road |
malaga, west australia 6090 |
AS 6090 |
|
Manufacturer (Section G) |
ADMEDUS REGEN PTY LTD |
26 harris road |
|
malaga, west australia 6090 |
AS
6090
|
|
Manufacturer Contact |
seona
roberts
|
26 harris road |
malaga, west australia 6090
|
AS
6090
|
|
MDR Report Key | 9367773 |
MDR Text Key | 168054796 |
Report Number | 3010805634-2019-00006 |
Device Sequence Number | 1 |
Product Code |
DXZ
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K130872 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/06/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | EC0404 |
Device Catalogue Number | C0404 |
Device Lot Number | M14019-20-04 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/02/2018 |
Initial Date FDA Received | 11/25/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 47 YR |
|
|