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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES COLD THERAPY UNIT, AUTOMATIC TEMP CONTROL; PACK, HOT OR COLD, WATER CIRCULATING
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DEROYAL INDUSTRIES COLD THERAPY UNIT, AUTOMATIC TEMP CONTROL; PACK, HOT OR COLD, WATER CIRCULATING Back to Search Results
Catalog Number T505
Device Problem Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 07/14/2014
Event Type  malfunction  
Event Description
Customer said there is sparks coming from the connection were the outlet gates into the machine.Customer also having problems with the blue is rubbing off and not allowing the velcro to stick.
 
Manufacturer Narrative
No further info is available at this time.Will provide follow ups if info becomes available.
 
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Brand Name
COLD THERAPY UNIT, AUTOMATIC TEMP CONTROL
Type of Device
PACK, HOT OR COLD, WATER CIRCULATING
Manufacturer (Section D)
DEROYAL INDUSTRIES
1595 highway 33 south
new tazewell TN 37825
Manufacturer Contact
200 debusk lane
powell, TN 37849
8653622333
MDR Report Key4042193
MDR Text Key18731093
Report Number2320762-2014-00017
Device Sequence Number1
Product Code ILO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 08/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberT505
Device Lot Number35861791
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/14/2014
Event Location Hospital
Date Manufacturer Received07/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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