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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUBLIN REFURBISH COOLTONE SYSTEM; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
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DUBLIN REFURBISH COOLTONE SYSTEM; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING Back to Search Results
Catalog Number CS-MS-002-D-00
Device Problem Unintended Electrical Shock (4018)
Patient Problem Electric Shock (2554)
Event Date 10/15/2021
Event Type  Injury  
Event Description
A treatment provider reported that a patient treated to the glutes with cooltone system on (b)(6) 2021 and patient felt a electric shock feeling.
 
Manufacturer Narrative
Submitting report as importer.Manufacturer, (b)(4), is being notified of this report.
 
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Brand Name
COOLTONE SYSTEM
Type of Device
STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
Manufacturer (Section D)
DUBLIN REFURBISH
4410 rosewood dr
dublin CA 94558
Manufacturer (Section G)
ZIMMER MEDIZINSYSTEME GMBH
junkersstrasse 9
neu-ulm
Manufacturer Contact
terry ingram
12331-a riata trace parkway
austin, TX 78727
8479366324
MDR Report Key15784247
MDR Text Key303550111
Report Number3007215625-2022-01735
Device Sequence Number1
Product Code NGX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192940
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/11/2022
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 Health Professional
Device Catalogue NumberCS-MS-002-D-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2022
Distributor Facility Aware Date10/15/2021
Date Report to Manufacturer11/11/2022
Initial Date Manufacturer Received 10/15/2021
Initial Date FDA Received11/11/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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