MAUDE Adverse Event Report: DJO, LLC DONJOY; COOL TROM BRACE,SHORT

Model Number 11-0292-2-06000

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 10/17/2017

Event Type  Injury  

Event Description

Complaint received that alleges "patient had just had acl graft surgery (b)(6) - he rcvd brace in hospital (b)(6) was fitted with brace in bed, decided to take a walk got out of bed-fell back on bed and the brace broke-hospital discarded the brace- and pt re-tore the acl graft.Pt is currently still in hospital will have to undergo surgery again".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.

• Brand Name: DONJOY
• Type of Device: COOL TROM BRACE,SHORT
• 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, 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663
• MDR Report Key: 6979725
• MDR Text Key: 90324995
• Report Number: 9616086-2017-00019
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

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: No Information
• Device Model Number: 11-0292-2-06000
• 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: 10/26/2017
• 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): Hospitalization