COOLTONE 5034 CS-MS-002-D-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for COOLTONE 5034 CS-MS-002-D-00 manufactured by Zimmer Medizinsysteme Gmbh.

Event Text Entries

[184980389] On (b)(6) 2020 allergan received a report regarding a patient who sustained an abdominal burn from a metal button on clothing worn during 2-minute cooltone treatments to both abdomen and buttocks. Prior to the cooltone treatment, the patient was also treated with a 5-minute session using emsculpt, a non-allergan product. It was stated that the patient's abdominal treatment area had decreased sensation due to prior abdominoplasty. The burn was diagnosed as 3rd degree and is healing well following debridement and topical antibiotics, corticosteroids, and scar-minimization ointments. The cooltone user manual states that metallic objects should be at least 1. 2 meters away from the device and its accessories during use. Allergan is in contact with the treatment provider in order to obtain additional follow-up information. If additional information is received, the event will be re-assessed, and a follow-up report will be submitted. Based on the information currently available to the device importer, zeltiq aesthetics (allergan), a serious injury possibly caused by use error has occurred during cooltone treatment. An initial 30-day mdr was submitted by allergan to the fda on 06-mar-2020, with mfr report # 8010720-2020-00001. The said report number, however, was incorrect since it used the manufacturer fei and not the importer number. To correct this issue, this report was submitted with importer report # - 3007215625-2020-30000 and was tagged as an "initial report" for that report number. Section f - for use by user facility/importer, was also completed in this submission, all information obtained thus far was forwarded to the manufacturer, zimmer medizinsysteme (b)(4), which is the responsible party for completing the device investigation, root cause identification and determination if a device malfunction had occurred.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007215625-2020-30000
MDR Report Key9881201
Date Received2020-03-25
Date of Report2020-03-25
Date Facility Aware2020-02-11
Report Date2020-03-25
Date Reported to FDA2020-03-25
Date Reported to Mfgr2020-03-07
Date Added to Maude2020-03-25
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOOLTONE
Generic NameSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
Product CodeNGX
Date Received2020-03-25
Model Number5034
Catalog NumberCS-MS-002-D-00
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerZIMMER MEDIZINSYSTEME GMBH
Manufacturer AddressJUNKERSSTRASSE 9 NEU-ULM, 89231 GM 89231


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-25

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