Brand Name | CONTOUR VL SOFT PERCULFEX 4.8X22 |
Type of Device | STENT, URETERAL |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
2546 first st |
propark el coyol alajuela, cr |
|
MDR Report Key | 16700957 |
MDR Text Key | 313005899 |
Report Number | MW5116430 |
Device Sequence Number | 1 |
Product Code |
FAD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
04/04/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/06/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | M0061801550 |
Device Lot Number | 30888975 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 36 YR |
Patient Sex | Female |
Patient Weight | 108 KG |
Patient Ethnicity | Non Hispanic |
|
|