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

Catalog Number CS-MS-002-D-00

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

Submitting as importer.Manufacturer, zimmer medizinsysteme, is being notified of this report.The applicator has no electrical wire exposures for any electrical shock, and was tested directly to body application, there was no electric shock felt, but only magnetic field intensity.The field reported complaint regarding paddle shock, could not be duplicated.

Event Description

Allergan aeathetics received report that a patient received cooltone treatment to the lower abdomen and experienced electric shock during treatment.The reported indicated that the patient was doing good following the event.

Event Description

Allergan aeathetics received report that a patient received cooltone treatment to the left and right buttocks on (b)(6) 2022 and experienced electric shock to the right buttock during treatment.The reported indicated that the patient was doing good following the event.

Manufacturer Narrative

H11: additional change and/or corrected data.

• 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): DUBLIN REFURBISH; 4410 rosewood dr; dublin CA 94558
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; austin, TX 78727 ; 8479366324
• MDR Report Key: 15612396
• MDR Text Key: 301818924
• Report Number: 3007215625-2022-01573
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2022
• Distributor Facility Aware Date: 09/15/2022
• Date Report to Manufacturer: 10/14/2022
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/15/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/08/2022
• 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 Age: 48 YR
• Patient Sex: Female