Brand Name | FLEXIMA APDL |
Type of Device | TUBE, DRAINAGE, SUPRAPUBIC |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
2546 calle primera |
propark, coyol |
alajuela |
CS
|
|
Manufacturer Contact |
jay
johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 8772067 |
MDR Text Key | 150421482 |
Report Number | 2134265-2019-07902 |
Device Sequence Number | 1 |
Product Code |
FFA
|
UDI-Device Identifier | 08714729323112 |
UDI-Public | 08714729323112 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K944290 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/09/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/09/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2022 |
Device Model Number | 30935 |
Device Catalogue Number | 30935 |
Device Lot Number | 0023258723 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/16/2019 |
Date Manufacturer Received | 06/15/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/01/2019 |
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 |
|
|