Brand Name | PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP |
Type of Device | DEFIB/PACING ELECTRODE |
Manufacturer (Section D) |
BIO-DETEK INCORPORATED |
525 narragansett park drive |
pawtucket RI 02861 |
|
MDR Report Key | 10680211 |
MDR Text Key | 211365116 |
Report Number | 1218058-2020-00080 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
Combination Product (y/n) | N |
PMA/PMN Number | K960676 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Type of Report
| Initial,Followup |
Report Date |
10/01/2020 |
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 |
Other
|
Device Expiration Date | 06/18/2021 |
Device Model Number | 8900-4005 |
Device Catalogue Number | 8900-4005 |
Device Lot Number | 2520B |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/30/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/01/2020
|
Initial Date FDA Received | 10/14/2020 |
Supplement Dates Manufacturer Received | 10/01/2020
|
Supplement Dates FDA Received | 11/30/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|