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Adverse Event Report

BATTLE CREEK EQUIPMENT CO THERMOPHORE AUTOMATIC MOIST HEAT PACK   back to search results
Model Number 055
Event Date 01/01/2000
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported the cord emitted sparks.

 
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Brand NameTHERMOPHORE
Type of DeviceAUTOMATIC MOIST HEAT PACK
Baseline Brand NameTHERMOPHORE
Baseline Generic NameHEAT PACK - AC POWERED
Baseline Catalogue NumberNA
Baseline Model Number055
Baseline Device FamilyTHERMOPHORE
Baseline Device 510(K) NumberK851237
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed01/01/1913
Manufacturer (Section F)
BATTLE CREEK EQUIPMENT CO
307 west jackson st
battle creek MI 49017 2385
Manufacturer (Section D)
BATTLE CREEK EQUIPMENT CO
307 west jackson st
battle creek MI 49017 2385
Manufacturer (Section G)
HEMI
po box 736
fremont IN 46737
Manufacturer Contact
steven martin
307 west jackson street
battle creek , MI 49017
(616) 962 -6181
Device Event Key295268
MDR Report Key305098
Event Key286700
Report Number1811605-2000-00148
Device Sequence Number1
Product CodeIRT
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Remedial Action Repair
Type of Report Initial
Report Date 10/30/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL Number055
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/30/2000
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/30/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1990
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 January 30, 2009

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