MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA DURA-STICK PREM 5CM SQUARE 4/PK; ELECTRODE, CUTANEOUS

Model Number 42209

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

Patient Problem Skin Irritation (2076)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Operator of device: unknown.No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the patient experienced an allergic reaction to the electrodes.Betamethasone cream was prescribed to treat the patient.No further information was provided.

• Brand Name: CHATTANOOGA DURA-STICK PREM 5CM SQUARE 4/PK
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO TUNISIE; zone industrielle poudriere 1; aout; sfax 3002 ; TS 3002
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8909883
• MDR Text Key: 154903439
• Report Number: 3007615436-2019-00003
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 00888912341073
• UDI-Public: (01)00888912341073(17)210228(10)AM000050265
• Combination Product (y/n): N
• PMA/PMN Number: K874469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/28/2021
• Device Model Number: 42209
• Device Lot Number: AM000050265
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention