Brand Name | CRYOPATCH SG PULMONARY HEMI-ARTERY |
Type of Device | HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT |
Manufacturer (Section D) |
CRYOLIFE, INC. ¿ KENNESAW |
1655 roberts blvd. nw |
kennesaw GA 30144 |
|
Manufacturer (Section G) |
CRYOLIFE, INC. ¿ KENNESAW |
1655 roberts blvd. nw |
|
kennesaw GA 30144 |
|
Manufacturer Contact |
rochelle
maney
|
1655 roberts blvd |
kennesaw, GA 30144
|
7704193355
|
|
MDR Report Key | 11347870 |
MDR Text Key | 232522715 |
Report Number | 1063481-2021-00008 |
Device Sequence Number | 1 |
Product Code |
OHA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K092021 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/21/2021 |
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 |
No Information
|
Device Model Number | SGPH00 |
Device Lot Number | 156266 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 01/22/2021 |
Initial Date Manufacturer Received |
01/22/2021 |
Initial Date FDA Received | 02/19/2021 |
Supplement Dates Manufacturer Received | 01/22/2021
|
Supplement Dates FDA Received | 04/21/2021
|
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;
|
|
|