Brand Name | MAXCORE DISPOSABLE BIOPSY SYSTEM |
Manufacturer (Section D) |
BARD REYNOSA S.A. DE C.V. |
reynosa, tamaulipas |
MX |
|
Manufacturer (Section G) |
BARD REYNOSA S.A. DE C.V. |
blvd. montebello #1 |
parque industrial colonial |
reynosa, tamaulipas |
MX
|
|
Manufacturer Contact |
christy
lewis
|
8195 industrial blvd. |
covington, GA 30014
|
7707846100
|
|
MDR Report Key | 4196594 |
MDR Text Key | 16560712 |
Report Number | 1018233-2014-00285 |
Device Sequence Number | 1 |
Product Code |
KNW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K874585 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Unknown
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
09/23/2014 |
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 | MC1820 |
Device Lot Number | REYC2853 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 10/07/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/23/2014 |
Initial Date FDA Received | 10/17/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
|
|