MAUDE Adverse Event Report: DJ, LLC AIRCAST; CRYOCUFF COOLER

Catalog Number 10A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Skin Discoloration (2074); Tingling (2171); Numbness (2415); Vascular System (Circulation), Impaired (2572)

Event Date 12/16/2013

Event Type  Injury  

Event Description

Complaint received through the medwatch system that alleges "post-surgical application of ankle cryo/cuff.Pt sent home with instructions to apply cryo/cuff to right ankle; on 2 hrs/off 1 hr.Pt and mother left cryo/cuff on continuously for 4 days.Pt went to dr for post-surgical follow up and reported numbness and tingling.Dr observed dark blue/gray toes and cold foot.Pt required below the knee amputation".Questionnaire not received from clinician and/or pt.During a phone conversation with the reporting party, they confirmed that the maude report contains all the date that they are able to provide.She also stated no additional info had become available to them since the original report.Product not returned to mfr for review.

• Brand Name: AIRCAST
• Type of Device: CRYOCUFF COOLER
• Manufacturer (Section D): DJ, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana b.c. 2224 4; MX 22244
• Manufacturer Contact: 1430 decision street; vista, CA 92081 ; 7607271280
• MDR Report Key: 4038153
• MDR Text Key: 4905849
• Report Number: 9616086-2014-00014
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 10A
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Age: 6 YR