Brand Name | 11.5FX15CM TRI-FLOW |
Type of Device | TRI-FLOW CATHETER |
Manufacturer (Section D) |
MEDICAL COMPONENTS, INC. |
1499 delp drive |
harleysville PA 19438 |
|
MDR Report Key | 8874293 |
MDR Text Key | 159369178 |
Report Number | 2518902-2019-00049 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 00884908060560 |
UDI-Public | 884908060560 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Type of Report
| Initial,Followup |
Report Date |
11/05/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | XTP3116MT-J |
Device Catalogue Number | XTP3116MT-J |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/31/2019 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/29/2019 |
Initial Date FDA Received | 08/08/2019 |
Supplement Dates Manufacturer Received | 07/29/2019
|
Supplement Dates FDA Received | 11/05/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 37 YR |
|
|