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

Model Number 5034

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

Based on the information currently available to the device importer, zeltiq aesthetics, inc, a serious injury has occurred.All information obtained thus far was forwarded to the manufacturer, zimmer (b)(4), the manufacturer of the device.It is the responsibility of zimmer (b)(4) to perform the device investigation.A supplemental report will be submitted upon completion of the investigation and/or receipt of any additional information.

Event Description

On (b)(6) 2020, allergan received a report that a patient was treated to the bilateral inner thighs with cooltone on (b)(6) 2020 and presented with a third-degree burn to the right inner thigh.The area was not covered with clothing; however, the applicator was covered with a bonnet.The skin/tissue was open, and the burn healed from the inside out.The area now presents with a scar.The device investigation is pending.

• Brand Name: COOLTONE
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm, bavaria 89231 ; GM 89231
• MDR Report Key: 11189654
• MDR Text Key: 227473363
• Report Number: 3007215625-2021-40001
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2021

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2021
• Distributor Facility Aware Date: 12/29/2020
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/06/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other