Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
MEDICAL COMPONENTS, INC. |
1499 delp drive |
harleysville PA 19438 |
|
MDR Report Key | 9075222 |
MDR Text Key | 158791648 |
Report Number | 9075222 |
Device Sequence Number | 1 |
Product Code |
DQO
|
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 |
09/05/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/17/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | MR28010721 |
Device Lot Number | MNKR550 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/05/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 09/17/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|