Brand Name | POWERPORT ISP M.R.I. IMPLANTABLE PORT |
Type of Device | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
Manufacturer (Section D) |
BARD ACCESS SYSTEMS, INC. |
605 north 5600 west |
salt lake city UT 84116 |
|
MDR Report Key | 12293298 |
MDR Text Key | 265582055 |
Report Number | 12293298 |
Device Sequence Number | 1 |
Product Code |
LJT
|
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 |
08/04/2021,08/03/2021 |
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 Model Number | 1808560 |
Device Catalogue Number | 1808560 |
Device Lot Number | REBQ2423 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/04/2021 |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/09/2021 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/09/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|