MAUDE Adverse Event Report: DUBLIN COOLTONE APPLICATOR; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Catalog Number CS-A4-EMS-XX

Device Problems Leak/Splash (1354); Structural Problem (2506)

Patient Problem Insufficient Information (4580)

Event Date 09/06/2022

Event Type  Injury  

Event Description

Allergan aesthetics received a report of cooltone applicator exploded and leaked all over a patient, went all over the room, splattered the walls, and it got in his eye and patient was seen by a physician.Though requested, additional event information including injury to eye and patient treatment was not provided.

Manufacturer Narrative

Submitting as importer.Manufacturer, (b)(4), has been notified of this report.

• Brand Name: COOLTONE APPLICATOR
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): DUBLIN; 4410 rosewood dr; pleasanton CA 94588
• Manufacturer (Section G): DUBLIN; 4410 rosewood dr; pleasanton CA 94588
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; austin, TX 78727
• MDR Report Key: 15547919
• MDR Text Key: 301235492
• Report Number: 3007215625-2022-01528
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2022

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-A4-EMS-XX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2022
• Distributor Facility Aware Date: 09/06/2022
• Date Report to Manufacturer: 10/05/2022
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/05/2022
• 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