Brand Name | BIOGLUE SYRINGE 5-PACK, 10ML, JAPAN |
Type of Device | GLUE, SURGICAL, ARTERIES |
Manufacturer (Section D) |
CRYOLIFE, INC. |
1655 roberts blvd. nw |
kennesaw GA 30144 |
|
MDR Report Key | 12253232 |
MDR Text Key | 264501191 |
Report Number | 1063481-2021-00023 |
Device Sequence Number | 1 |
Product Code |
MUQ
|
Combination Product (y/n) | N |
PMA/PMN Number | P010003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Type of Report
| Initial,Followup |
Report Date |
08/06/2021 |
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 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/07/2021 |
Initial Date FDA Received | 07/30/2021 |
Supplement Dates Manufacturer Received | 07/07/2021
|
Supplement Dates FDA Received | 08/06/2021
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|