Brand Name | GROSHONG NXT CLEARVUE 4F SL TPS |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS |
Manufacturer (Section D) |
C.R. BARD, INC. (BASD) -3006260740 |
605 north 5600 west |
salt lake city 84116 |
|
Manufacturer (Section G) |
BARD REYNOSA S.A. DE C.V. -9617592 |
blvd. montebello #1 |
parque industrial colonial |
reynosa, tamaulipas 88780 |
MX
88780
|
|
Manufacturer Contact |
kayla
olsen
|
605 north 5600 west |
salt lake city 84116
|
8015950700
|
|
MDR Report Key | 11274595 |
MDR Text Key | 231205056 |
Report Number | 3006260740-2021-00193 |
Device Sequence Number | 1 |
Product Code |
LJS
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | 801(E) |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/15/2021 |
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 |
Health Professional
|
Device Catalogue Number | CK000516 |
Device Lot Number | REDX4726 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/14/2021
|
Initial Date FDA Received | 02/03/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/01/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|