MAUDE Adverse Event Report: DJO, LLC DONJOY COOL, TROM ADVANCE; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-9114-9

Device Problem Collapse (1099)

Patient Problems Edema (1820); Tissue Damage (2104)

Event Date 10/02/2019

Event Type  Injury  

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.

Event Description

It was reported that the patient put weight on the leg he got surgery on and the frame of the brace broke causing him to fall down.Impression of magnetic resonance imaging (mri) includes suspicion of partial re-tear of the quadriceps tendon.Otherwise, patient experienced edema and possible small hematoma.No further information (definitive patient outcome, treatment, etc.) is currently available.

• Brand Name: DONJOY COOL, TROM ADVANCE
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• 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, b.c. 22244 ; MX 22244
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9243964
• MDR Text Key: 178234433
• Report Number: 9616086-2019-00079
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 11-9114-9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• 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
• Patient Age: 62 YR