Brand Name | BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN |
Type of Device | GLUE,SURGICAL,ARTERIES |
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 | 12365505 |
MDR Text Key | 268065741 |
Report Number | 1063481-2021-00025 |
Device Sequence Number | 1 |
Product Code |
MUQ
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
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 |
10/18/2021 |
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 | BG3510-5-J |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 07/28/2021 |
Initial Date Manufacturer Received |
07/28/2021 |
Initial Date FDA Received | 08/25/2021 |
Supplement Dates Manufacturer Received | 07/28/2021
|
Supplement Dates FDA Received | 10/18/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
|
Patient Age | 61 YR |
|
|