Brand Name | BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET |
Type of Device | SKYLITE BASKET |
Manufacturer (Section D) |
C.R. BARD, INC. (COVINGTON) -1018233 |
8195 industrial blvd |
covington GA 30014 |
|
Manufacturer (Section G) |
C.R. BARD, INC. (COVINGTON) -1018233 |
8195 industrial blvd |
|
covington GA 30014 |
|
Manufacturer Contact |
yonic
anderson
|
8195 industrial blvd |
covington, GA 30014
|
7707846100
|
|
MDR Report Key | 8892379 |
MDR Text Key | 184698354 |
Report Number | 1018233-2019-04700 |
Device Sequence Number | 1 |
Product Code |
FFL
|
UDI-Device Identifier | 00801741111495 |
UDI-Public | (01)00801741111495 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other,user facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/14/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/14/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/30/2021 |
Device Model Number | 042400 |
Device Catalogue Number | 042400 |
Device Lot Number | NGCY1644 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/06/2019 |
Date Manufacturer Received | 07/23/2019 |
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 |