Brand Name | MOZECTM NC- RX PTCA BALLOON DILATATION CATHETER |
Type of Device | RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER |
Manufacturer (Section D) |
MERIL LIFE SCIENCES PVT. LTD. |
bilakhia house, survey no. 135 |
muktanand marg |
chala, vapi 39619 1 |
IN 396191 |
|
Manufacturer (Section G) |
MERIL LIFE SCIENCES PVT. LTD. |
bilakhia house, survey no. 135 |
muktanand marg |
chala, vapi 39619 1 |
IN
396191
|
|
Manufacturer Contact |
narendra
patel
|
bilakhia house, survey no. 135 |
muktanand marg |
chala, vapi 39619-1
|
IN
396191
|
|
MDR Report Key | 7491074 |
MDR Text Key | 108140808 |
Report Number | 3009613036-2018-00013 |
Device Sequence Number | 1 |
Product Code |
LOX
|
UDI-Device Identifier | 18906029358223 |
UDI-Public | 18906029358223 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K160961 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Health Professional
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
05/07/2018 |
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 Expiration Date | 02/26/2020 |
Device Model Number | MNC25015 |
Device Catalogue Number | MNC25015 |
Device Lot Number | MNCF33 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/12/2018 |
Initial Date FDA Received | 05/07/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/27/2017 |
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 Age | 60 YR |