MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA APPLICATOR 5CM BLUE CALIBR; ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	27335
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.This report is being submitted per receipt of user facility medwatch report # (b)(4).
Event or Problem Description
It was reported that "patient reported sensation of being stabbed by needles, after four minutes into the low level ultrasound procedure." user facility medwatch # (b)(4) was forwarded to the manufacturer, reporting that "pt was being ultrasound with unit and reported a sensation of being stabbed with a needle." there was no adverse event indicated in association with the reported product problem.

• Brand Name: CHATTANOOGA APPLICATOR 5CM BLUE CALIBR
• Common Device Name: ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8695850
• Report Number: 9616086-2019-00025
• Device Sequence Number: 11334270
• Product Code: IMI
• UDI-Device Identifier: 00888912021876
• UDI-Public: 00888912021876
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K031116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL
• Patient Age: 42 YR