Brand Name | THERMOMETER DUAL SCALE ORAL CLINICAL |
Type of Device | THERMOMETER, ELECTRONIC, CLINICAL |
Manufacturer (Section D) |
HANGZHOU SEJOY ELEC & INST CO LTD |
bldg 2 no 202 west lake econom |
hangzhou 130 3 0003 |
CH 130 300030 |
|
Manufacturer (Section G) |
HANGZHOU SEJOY ELEC & INST CO LTD |
bldg 2 no 202 west lake econom |
|
hangzhou 130 3 0003 |
CH
130 300030
|
|
Manufacturer Contact |
michele
donatich
|
1500 waukegan rd |
waukegan, IL 60085
|
|
MDR Report Key | 6083487 |
MDR Text Key | 59837547 |
Report Number | 1423537-2016-00056 |
Device Sequence Number | 1 |
Product Code |
FLL
|
UDI-Device Identifier | 00885380023883 |
UDI-Public | (01)00885380023883 |
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 |
11/07/2016 |
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 Model Number | 16811-DS |
Device Catalogue Number | 16811-DS |
Device Lot Number | 59776004160146-SH |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/20/2016 |
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 09/30/2016 |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
09/30/2016
|
Initial Date FDA Received | 11/07/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 10 DA |