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

Model Number	5034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Wheal(s) (2241); Urticaria (2278)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Allergan received report that a female patient was treated to the abdomen with cooltone on (b)(6) 2020.The treatment provider stated that a cover was used over the applicator before it was placed over the patient's skin.On the following day the patient developed hives on the treated area that had later spread throughout her body.On (b)(6) 2020, the patient was hospitalized due to hives in the vaginal and oral mucosa and difficulty breathing.The patient was given oral (b)(6) and was discharged on (b)(6) 2020.The patient was advised by her physician that the formation of hives may have been caused by overstimulation after prolonged periods of no exercise.

• Brand Name: COOLTONE
• Common Device Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm, 89231 ; GM 89231
• MDR Report Key: 9954560
• Report Number: 3007215625-2020-30008
• Device Sequence Number: 2765228
• Product Code: NGX
• UDI-Device Identifier: 04053815076698
• UDI-Public: (01)04053815076698(11)200212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2020
• Report Date (Section F): 04/13/2020

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
• Operator of Device: Health Professional
• Device Model Number: 5034
• Device Catalogue Number: CS-MS-002-D-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/17/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Date Report Sent to FDA: 04/13/2020