MAUDE Adverse Event Report: DJO, LLC DONJOY ICEMAN CLEARCUBE W/UNIV WRAP-ON PAD, NS, RH, INT'L; PACK, HOT OR COLD, WATER CIRCULATING

Model Number 11-1640

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Date 07/09/2019

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 sparks came out of the power cords, and the end user suffered some degree of burning.It is unknown if this was on account of the formentioned sparks or due to frostbite.Further information was requested.

• Brand Name: DONJOY ICEMAN CLEARCUBE W/UNIV WRAP-ON PAD, NS, RH, INT'L
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• 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
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8860952
• MDR Text Key: 153375795
• Report Number: 9616086-2019-00055
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00888912218146
• UDI-Public: 00888912218146
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K955057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11-1640
• Device Lot Number: 082718
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2018
• 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