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

Model Number 5034

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Wheal(s) (2241); Urticaria (2278)

Event Date 03/13/2020

Event Type  Injury  

Event 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
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm, 89231 ; GM 89231
• MDR Report Key: 9954560
• MDR Text Key: 191866127
• Report Number: 3007215625-2020-30008
• Device Sequence Number: 1
• Product Code: NGX
• UDI-Device Identifier: 04053815076698
• UDI-Public: (01)04053815076698(11)200212
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 04/13/2020
• Distributor Facility Aware Date: 03/17/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other