Brand Name | THERMOPHORE AUTOMATIC HEAT PACK |
Type of Device | ELECTRIC MOIST HEAT PACK |
Manufacturer (Section D) |
BATTLE CREEK EQUIPMENT |
fremont IN |
|
Manufacturer Contact |
randy
newsome
|
702 south reed street |
fremont, IN 46737
|
2699626181
|
|
MDR Report Key | 3940452 |
MDR Text Key | 4534161 |
Report Number | 1811605-2014-00096 |
Device Sequence Number | 1 |
Product Code |
IRT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,User Facility |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
04/16/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/17/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 055 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/08/2014 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 04/08/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/01/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|