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

Catalog Number CS-MS-002-D-00_R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/04/2022

Event Type  Injury  

Manufacturer Narrative

Submitting as importer.Manufacturer, zimmer medizinsysteme, is being notified of this report.

Event Description

Allergan aesthetics received a report that a patient received a cooltone treatment to the abdomen on (b)(6) 2022 and presented with second degree burn post treatment.The patient was treated for full thickness sore with antibiotic keflex and wound care with improvement noted.

• Brand Name: COOLTONE SYSTEM
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm ; GM
• Manufacturer (Section G): ZIMMER MEDIZINSYSTEME GMBH; pleasanton CA 94588
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; austin, TX 78727 ; 8479366324
• MDR Report Key: 16665462
• MDR Text Key: 312534237
• Report Number: 3007215625-2023-00419
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2023

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 Catalogue Number: CS-MS-002-D-00_R
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female