Brand Name | RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH. |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
TERUMO CORPORATION, ASHITAKA |
150 maimaigi-cho |
fujinomiya city, 418 |
JA 418 |
|
MDR Report Key | 9460826 |
MDR Text Key | 172266262 |
Report Number | 2243441-2019-00121 |
Device Sequence Number | 1 |
Product Code |
DQO
|
UDI-Device Identifier | 04987350772077 |
UDI-Public | 04987350772077 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/12/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/12/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/31/2022 |
Device Model Number | RF*ZB5410GA |
Device Catalogue Number | CG409 |
Device Lot Number | 190422 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/12/2019 |
Distributor Facility Aware Date | 11/14/2019 |
Device Age | 7 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/14/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|