MAUDE Adverse Event Report: DONJOY STERILE REGULATERD COLD PAD, UNIV, OAM, S. RH; COLD THERAPY PAD

Lot Number 140298

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problems Pain (1994); Swelling (2091)

Event Date 01/26/2016

Event Type  Injury  

Event Description

Patient had orthopedic knee surgery.A cold therapy device (machine and pad) are used to reduce pain and swelling from joint surgery.The pad was defective and leaked the solution onto the patient's dressing over the incision.It is thought that there is low risk of infection for the patient from the solution.Two patients experienced leaks from the pads on the same day and distributor removed the entire lot # from storage.

• Brand Name: STERILE REGULATERD COLD PAD, UNIV, OAM, S. RH
• Type of Device: COLD THERAPY PAD
• Manufacturer (Section D): DONJOY; 1430 decision st.; vista CA 92081
• MDR Report Key: 5403655
• MDR Text Key: 37347185
• Report Number: MW5059827
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 140298
• Other Device ID Number: 11-0801-9-00000
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR