Brand Name | TUBING SUCTION 9/32'' |
Type of Device | TUBING SUCTION 9/32'' |
Manufacturer (Section D) |
GUANGZHOU WELL LEAD |
c-4 jinhu industrial estate, |
jualong, panyu |
guangzhou 51143 4 |
CH 511434 |
|
Manufacturer (Section G) |
GUANGZHOU WELL LEAD |
c-4 jinhu industrial estate, |
jualong, panyu |
guangzhou 51143 4 |
CH
511434
|
|
Manufacturer Contact |
michele
donatich
|
1500 waukegan road |
waukegan, IL 60085
|
8478876412
|
|
MDR Report Key | 5178033 |
MDR Text Key | 29931069 |
Report Number | 1423537-2015-00070 |
Device Sequence Number | 1 |
Product Code |
BYX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
10/26/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/26/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | N710 |
Device Catalogue Number | N710 |
Device Lot Number | 15033139E-LSH |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/28/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|