MAUDE Adverse Event Report: ZIMMER MEDIZINSYSTEME GMBH COOLTONE; STIMULATOR, MUSCLE, POWERED FOR MUSCLE CONDITIONING

Model Number 5034

Device Problem Insufficient Information (3190)

Patient Problem Electric Shock (2554)

Event Date 02/22/2020

Event Type  Injury  

Event Description

Allergan received provider report that on (b)(6) 2020 a patient was being treated with cooltone and the device shut down mid treatment.The treatment provider experienced an electric shock when they attempted to power the machine back on.The treatment provider then attempted to unplug the device and experienced an electric shock up their arm.

Manufacturer Narrative

Additional information: on july 07, 2020, allergan received additional information from the treatment provider.The treatment provider reported that the electric shock that was previously reported was so strong it make her stumble back a few steps.She reported her right arm was aching for approximately one week following the event.She also reported that she was wearing metallic nail polish and the shock removed the polish off of her right hand.She reported that the treatment room has wood flooring and there was no rug or mat placed between the floor and the device or treatment bed.Correction to a3 and d10.

• Brand Name: COOLTONE
• Type of Device: STIMULATOR, MUSCLE, POWERED FOR MUSCLE CONDITIONING
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm, 98231 ; GM 98231
• MDR Report Key: 9918533
• MDR Text Key: 192162091
• Report Number: 3007215625-2020-30001
• Device Sequence Number: 1
• Product Code: NGX
• UDI-Device Identifier: 04053815076698
• UDI-Public: (01)04053815076698(11)200212
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 04/02/2020,08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5034
• Device Catalogue Number: CS-MS-002-D-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2020
• Distributor Facility Aware Date: 07/07/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other