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

Model Number 5034

Device Problem Overheating of Device (1437)

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

Event Date 03/09/2020

Event Type  Injury  

Event Description

Allergan aesthetics received a report that a patient received a cooltone treatment to the bilateral inner thighs on (b)(6) 2020 and presented with third-degree burn post treatment to the right inner thigh.

Manufacturer Narrative

Submitting as importer.Manufacturer, zimmer medizinsysteme, is being notified of this report.This is a supplemental report from previously submitted report migrated from cpr - (b)(4).The applicator was received for testing.The testing found overheating of applicator, there was overheating by 1-2 degrees higher than the allowed tolerance.

Event Description

Allergan received a report that a male patient was treated on (b)(6) 2020 to the bilateral inner thighs with cooltone and experienced a third-degree burn to the right inner thigh.The bilateral inner thigh area was not covered with clothing during treatment; however, the applicator was covered with a bonnet.The skin/tissue in the right-side inner thigh was open, and the burn healed from the inside out.Photos show a deep blackened eschar.The area now presents with a scar.On (b)(6) 2020 the treatment office reported both of their cooltone applicators were leaking.The exact location of the leaks was unknown.The customer subsequently attempted to use the applicators and received an overheat alert.The two applicators were replaced.The patient received three treatments with cooltone to the abdomen, on (b)(6) 2020, (b)(6) 2020, and (b)(6) 2020.Following the third treatment, the patient experienced redness and a superficial burn to the treated area.

Manufacturer Narrative

H11: corrected data.Subsequent to the submission of previous medwatch report, it was noted that the below information was missed from section h10.The report is a supplemental report to previously submitted medwatch report uf/importer report# 3007215625-2021-40001.

• 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
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; austin, TX 78727 ; 8479366324
• MDR Report Key: 16690421
• MDR Text Key: 312811570
• Report Number: 3007215625-2023-00429
• 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: 04/06/2023

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: 5034
• Device Catalogue Number: UNK COOLTONE
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/06/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Male