MAUDE Adverse Event Report: OSSUR UNLOADER ONE SMARTDOSING LM MD; OSTEOARTHRITIS KNEE BRACE

Model Number B-240618713

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

Patient Problems Cellulitis (1768); Skin Irritation (2076); Tissue Damage (2104)

Event Date 10/03/2016

Event Type  Injury  

Event Description

Patient wearing unloader one smartdosing lm md had blisters form while wearing the product.The blisters turned into cellulitis which was treated by the primary care physician.

Event Description

Patient wearing unloader one smartdosing lm md had blisters form while wearing the product.The blisters turned into cellulitis which was treated by the primary care physician.

• Brand Name: UNLOADER ONE SMARTDOSING LM MD
• Type of Device: OSTEOARTHRITIS KNEE BRACE
• Manufacturer (Section D): OSSUR; blvd hector teran teran 2102; edificio #1, col. de canon del; tijuana, baja california 2102 ; MX 2102
• Manufacturer (Section G): OSSUR; blvd hector teran teran 2102; edificio #1, col. de canon del; tijuana, baja california 2102 ; MX 2102
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9492757557
• MDR Report Key: 6033784
• MDR Text Key: 57625526
• Report Number: 3008523132-2016-00004
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-240618713
• Device Catalogue Number: B-240618713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention