Brand Name | CUNITI WIRE |
Type of Device | DAMON COPPER NITI WIRE |
Manufacturer (Section D) |
SDS DE MEXICO |
s. de r.l. c.v. |
circuito sur no 31 |
mexicali, mexico c.p. |
|
Manufacturer (Section G) |
SDS DE MEXICO |
s. de r.l. de c.v. |
circuito sur no. 31 |
mexicali, mexico 21395 |
MX
21395
|
|
Manufacturer Contact |
suzette
rampair-johnson
|
1889 w. mission blvd |
pomona, CA 91766
|
9096713431
|
|
MDR Report Key | 8303269 |
MDR Text Key | 136993987 |
Report Number | 2016150-2019-00002 |
Device Sequence Number | 1 |
Product Code |
DZC
|
Combination Product (y/n) | N |
Reporter Country Code | NL |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/26/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Catalogue Number | 205-1902 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/14/2019
|
Initial Date FDA Received | 02/04/2019 |
Supplement Dates Manufacturer Received | 01/13/2019
|
Supplement Dates FDA Received | 04/26/2019
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|