MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL

Model Number 2761

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

Patient Problem Post Traumatic Wound Infection (2447)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Complaint received that alleges "the physical therapist noted a 1.0 inch by.5 inch oval shape wound with clean edges and black slough, (-) drainage, (-) erythema on left lower back/flank region.Pt denied pain on wound or periphery upon ocular inspect evaluation on (b)(6) 2016".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.

• Brand Name: CHATTANOOGA
• Type of Device: VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, mexico 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5897441
• MDR Text Key: 52831145
• Report Number: 9616086-2016-00022
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

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: Physical Therapist
• Device Model Number: 2761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 08/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other