Brand Name | BRAUN |
Type of Device | THERMOMETER |
Manufacturer (Section D) |
KAZ USA, INC., A HELEN OF TROY COMPANY |
400 donald lynch blvd. |
suite 300 |
marlborough MA 01752 |
|
Manufacturer (Section G) |
KAZ USA, INC., A HELEN OF TROY COMPANY |
|
|
|
|
Manufacturer Contact |
sonja
wilkinson
|
400 donald lynch boulevard |
suite 300 |
marlborough, MA 01752
|
5084907236
|
|
MDR Report Key | 5839494 |
MDR Text Key | 50936898 |
Report Number | 1314800-2016-00041 |
Device Sequence Number | 1 |
Product Code |
FLL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K103097 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Patient Family Member or Friend
|
Type of Report
| Initial |
Report Date |
07/26/2016 |
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 |
Patient Family Member or Friend
|
Device Model Number | IRT-3020 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/05/2016
|
Initial Date FDA Received | 08/02/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 18 MO |