MAUDE Adverse Event Report: ZIMMER MEDIZINSYSTEME GMBH COOLTONE; DERMAL COOLING PACK/VACUUM/MASSAGER

Model Number UNK CONTROL UNIT

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

Patient Problems Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/31/2023

Event Type  Injury  

Event Description

Allergan aesthetics received a report of a patient treated abdomen with cooltone on (b)(6) 2023 and (b)(6) 2023.The patient was medically treated in the emergency department on 31may2023 due to her skyla iud that had migrated upward.The emergency department physician was able to locate strings of the iud and repositioned device into the correct placement.Current status of the symptoms were resolved after er treatment.

Manufacturer Narrative

The cooltone¿ device is an electromagnetic muscle stimulation device indicated for improvement of abdominal tone and strengthening of the abdominal muscles and buttocks.The electromagnetic field induces a current of sufficient amplitude and duration to ultimately stimulate supramaximal muscle contractions.Temporary muscle spasm is an expected side effect of cooltone use.

• Brand Name: COOLTONE
• Type of Device: DERMAL COOLING PACK/VACUUM/MASSAGER
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm 89073
• MDR Report Key: 18402847
• MDR Text Key: 331476704
• Report Number: 3007215625-2023-13634
• 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: Physician
• Type of Report: Initial
• Report Date: 12/27/2023

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 Model Number: UNK CONTROL UNIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female