|
Model Number 055 |
Event Date 01/01/2001 |
Event Type
Malfunction
Patient Outcome
Other;
|
Event Description
|
It was reported the switch emitted sparks.
|
|
Search Alerts/Recalls
|
|
|
Brand Name | THERMOPHORE |
Type of Device | AUTOMATIC MOIST HEAT PACK |
Baseline Brand Name | THERMOPHORE |
Baseline Generic Name | HEAT PACK - AC POWERED |
Baseline Catalogue Number | NA |
Baseline Model Number | 055 |
Baseline Device Family | THERMOPHORE |
Baseline Device 510(K) Number | K851237 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
No
|
Baseline Preamendment? |
Yes
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | NA |
Date First Marketed | 01/01/1913 |
Manufacturer (Section F) |
BATTLE CREEK EQUIPMENT CO. |
307 west jackson st. |
battle creek MI 49017 |
|
Manufacturer (Section D) |
BATTLE CREEK EQUIPMENT CO. |
307 west jackson st. |
battle creek MI 49017 |
|
Manufacturer Contact |
steven
martin
|
307 west jackson street |
battle creek
, MI 49017 |
(616)
962
-6181
|
|
Device Event Key | 310860 |
MDR Report Key | 321319 |
Event Key | 302248 |
Report Number | 1811605-2001-00029 |
Device Sequence Number | 1 |
Product Code | IRT |
Report Source |
Manufacturer
|
Source Type |
Consumer
|
Reporter Occupation |
UNKNOWN
|
Remedial Action |
Repair
|
Type of Report
| Initial |
Report Date |
02/23/2001 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 03/14/2001 |
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 | 02/23/2001 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 02/23/2001 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/1996 |
Is The Device Single Use? |
No
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Reuse
|
|
|
Database last updated on February 28, 2009
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