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

Catalog Number CS-MS-002-D-00

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

Patient Problem Hernia (2240)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allergan aesthetics received a report of a patient treated with cooltone curve 120 applicator to the abdomen 26 times between 8/mar/2023 and 17/aug/2023 and 3 coolsculpting treatments to the lower abdomen and developed a hernia after treatment.Patient was diagnosed with an umbilical hernia by a medical professional on 17/aug/2023.According to the provider, no hernia was present in the area before treatment.

Event Description

Allergan aesthetics received a report of a patient treated with cooltone to the abdomen 26 times between on (b)(6) 2023 and received coolsculpting treatments to the abdomen on (b)(6) 2023 using the elite curve 120 applicator and developed a hernia after treatment.Patient was diagnosed with an umbilical hernia by a medical professional on (b)(6) 2023.According to the provider, no hernia was present in the area before treatment.

Manufacturer Narrative

Additional, changed, and/or corrected data: the patient was treated with both cool tone and coolsculpting and per review by abbvie's medical safety physicians, the relationship with the device cannot be clearly established.

• 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; junkersstrasse 9; neu-ulm ; GM
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; austin, TX 78727 ; 8479366324
• MDR Report Key: 17692651
• MDR Text Key: 322778629
• Report Number: 3007215625-2023-01360
• 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,Followup
• Report Date: 09/06/2023,10/25/2023

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
• Is the Reporter a Health Professional?: Yes
• Date Report Sent to FDA: 09/06/2023
• Distributor Facility Aware Date: 08/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/25/2023
• Date Device Manufactured: 03/13/2020
• 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
• Treatment: COOLSCULPTING.
• Patient Age: 58 YR
• Patient Sex: Male