Brand Name | SURESTEP |
Type of Device | CATHETER, RETENTION TYPE, BALLOON |
Manufacturer (Section D) |
C. R. BARD, INC. |
1211 mary magnan blvd |
madison GA 30650 |
|
MDR Report Key | 10991293 |
MDR Text Key | 220920173 |
Report Number | 10991293 |
Device Sequence Number | 1 |
Product Code |
EZL
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/23/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Catalogue Number | A942216 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/23/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 12/11/2020 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/11/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|