Brand Name | SUPERHERO GRAFT ADAPTER |
Type of Device | GRAFT ADAPTER |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
1600 w merit parkway |
south jordan 84095 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS, INC. |
1600 w merit parkway |
|
south jordan 84095 |
|
Manufacturer Contact |
katie
swenson, cqe, cba, cqpa
|
1600 w merit parkway |
south jordan 84095
|
8012081600
|
|
MDR Report Key | 8831570 |
MDR Text Key | 152352020 |
Report Number | 1721504-2019-00063 |
Device Sequence Number | 1 |
Product Code |
DSY
|
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | K124039 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/23/2019 |
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 Expiration Date | 07/31/2019 |
Device Catalogue Number | HERO1000/A |
Device Lot Number | H1255287 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/23/2019 |
Initial Date FDA Received | 07/26/2019 |
Supplement Dates Manufacturer Received | 08/12/2019
|
Supplement Dates FDA Received | 08/19/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/29/2018 |
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 |
Treatment | 8F SHEATH |
Patient Outcome(s) |
Death;
Life Threatening;
|
Patient Age | 65 YR |
|
|