Brand Name | BD PREPSTAIN¿ |
Type of Device | PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
Manufacturer (Section D) |
BECTON DICKINSON & CO. (SPARKS) |
7 loveton circle |
sparks MD 21152 |
|
Manufacturer (Section G) |
BECTON, DICKINSON & CO. (SPARKS) |
7 loveton circle |
|
sparks MD 21152 |
|
Manufacturer Contact |
phillip
emmert
|
9450 south state street |
sandy, UT 84070
|
8448235433
|
|
MDR Report Key | 17278681 |
MDR Text Key | 318847294 |
Report Number | 1119779-2023-00749 |
Device Sequence Number | 1 |
Product Code |
MKQ
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | P970018 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/29/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/07/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | 490100 |
Device Catalogue Number | 490100 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/16/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/26/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |