Brand Name | CANGAROO ENVELOPE |
Type of Device | MESH, SURGICAL |
Manufacturer (Section D) |
AZIYO BIOLOGICS, INC. |
1100 old ellis road |
ste 1200 |
roswell, ga |
|
Manufacturer (Section G) |
AZIYO BIOLOGICS, INC. |
1100 old ellis road |
ste 1200 |
roswell, ga |
|
Manufacturer Contact |
andrew
green
|
1100 old ellis road |
ste 1200 |
roswell, ga
|
|
MDR Report Key | 9781359 |
MDR Text Key | 188138931 |
Report Number | 3005619880-2020-00021 |
Device Sequence Number | 1 |
Product Code |
FTM
|
UDI-Device Identifier | 00859389005072 |
UDI-Public | 00859389005072 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K182255 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/03/2020 |
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 | CMCV-009-XLG |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/05/2020 |
Initial Date FDA Received | 03/03/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 76 YR |
|
|