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

Catalog Number CS-A4-EMS-XX

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

Manufacturer Narrative

Based on the information currently available to the device importer, (b)(4) a serious injury possibly caused by use error, has occurred during cooltone treatment.All information obtained thus far was forwarded to the manufacturer, zimmer medizinsysteme (b)(4), which is the responsible party for completing the device investigation, root cause identification and determination if a reportable malfunction has occurred.

Event Description

Allergan received a report regarding a patient who sustained an abdominal burn from a metal button on clothing worn during 2-minute treatments to both abdomen and buttocks.Prior to the cooltone treatment, the patient was also treated with a 5-minute session using emsculpt, a non-allergan product.It was stated that the patient¿s abdominal treatment area had decreased sensation due to prior abdominoplasty.The burn was diagnosed as 3rd degree and is healing well following debridement and topical antibiotics, corticosteroids, and scar-minimization ointments.The cooltone user manual states that metallic objects should be at least 1.2 meters away from the device and its accessories during use.Allergan is in contact with the treatment provider in order to obtain additional follow-up information.If additional information is received, the event will be re-assessed, and a follow-up report will be submitted.

• Brand Name: COOLTONE APPLICATOR
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm
• Manufacturer (Section G): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm
• Manufacturer Contact: jennifer cleto ; 4410 rosewood drive; pleasanton, CA 94588 ; 9256214130
• MDR Report Key: 9803064
• MDR Text Key: 182469206
• Report Number: 8010720-2020-00001
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• PMA/PMN Number: K182963
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2020

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 Catalogue Number: CS-A4-EMS-XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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