MAUDE Adverse Event Report: DONJOY, INC (FORMERLY SMITH & NEPHEW) DONJOY ICEMAN CRYOTHERAPY DEVICE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Necrosis (1971); Skin Discoloration (2074); Swelling (2091); Burn, Thermal (2530)

Event Date 10/19/2004

Event Type  Injury  

Event Description

(b)(6) female had surgery on (b)(6) 2004 to repair a partial torn anterior cruciate ligament.A donjoy iceman was applied post surgery with instructions.I was instructed to use the device constantly for 72 hours and intermittently thereafter, which i followed.On my first post-op visit, (b)(6) 2004, my knee appeared black and blue with blisters around the incisions.The doctor thought i might be allergic to latex due to the blisters that began forming near the incision areas.I continued to use the iceman intermittently and on (b)(6) 2004 i went to the emergency room due to swelling, blisters, bruising of the patella, and warmth.The emergency room physician suspected an infection although my white blood count was normal and no cultures were taken.On (b)(6) 2004 my doctor noted continued discoloration of my knee.By this time a large, black, rectangular eschar had developed.On (b)(6) 2004, my doctor urgently referred me to a plastic surgeon.Surgical skin debridement and irrigation of the eschar was performed on (b)(6) 2004 and a subsequent debridement was performed on (b)(6) 2005 along with a skin graft.Treatment of the wound continued for several months.On (b)(6) 2006, i had scar revision surgeries.In (b)(6) 2012, i first became aware that the iceman cryotherapy unit caused a non-freezing cold injury and that there is a history of such injuries being caused by the iceman.

• Brand Name: DONJOY ICEMAN CRYOTHERAPY DEVICE
• Type of Device: DONJOY ICEMAN CRYOTHERAPY DEVICE
• Manufacturer (Section D): DONJOY, INC (FORMERLY SMITH & NEPHEW)
• MDR Report Key: 3972957
• MDR Text Key: 4752250
• Report Number: MW5037529
• Device Sequence Number: 1
• Product Code: ILO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 17 YR
• Patient Weight: 64