Brand Name | REZUM |
Type of Device | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
|
marlborough MA 01752 |
|
Manufacturer Contact |
alyson
harris
|
4100 hamline avenue north |
building c |
saint paul, MN 55112
|
4089353452
|
|
MDR Report Key | 12993546 |
MDR Text Key | 282192170 |
Report Number | 2124215-2021-37721 |
Device Sequence Number | 1 |
Product Code |
KNS
|
Combination Product (y/n) | N |
Reporter Country Code | TD |
PMA/PMN Number | K191505 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Distributor |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
01/26/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/14/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Model Number | D2201 |
Device Catalogue Number | D2201 |
Device Lot Number | 0027797710 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/04/2022 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/30/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/13/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Treatment Data |
Date Received: 12/14/2021 Patient Sequence Number: 1 |
|
|