MAUDE Adverse Event Report: DJO, LLC DEFIANCE

Model Number UNKNOWN

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

Patient Problem Laceration(s) (1946)

Event Date 07/12/2017

Event Type  Injury  

Event Description

Complaint received that alleges "patient fell with her defiance.The medial passant above the knee split in half and pierced the leg artery in the lower part of her leg.This caused huge panic and a big bleeding in her leg.The artery was not completely slit, so the bleeding could be stopped.However, miss (b)(6) has now trouble with the wound healing".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.

Manufacturer Narrative

Product questionnaire received from clinician and/or patient.Treatment was interrupted; progress toward recovery was impeded.Treatment was required at the time.Patient did follow up with primary care doctor or emergency room for treatment.Woundhealing protocol was started due to difficulty with wound healing.Device disposed of as biohazrd waste due to blood contamination.Unable to confirm complaint from photograph received.

• Brand Name: DEFIANCE
• Type of Device: DEFIANCE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 3151 scott street; vista CA 92081 9663
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663
• MDR Report Key: 6740744
• MDR Text Key: 80931908
• Report Number: 2020737-2017-00002
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

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: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: No
• 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