MAUDE Adverse Event Report: DYNAREX CORPORATION DYNAREX INSTANT COLD PACK

Model Number 4512

Device Problem Physical Property Issue (3008)

Patient Problem Burn(s) (1757)

Event Date 12/27/2016

Event Type  Injury  

Manufacturer Narrative

At the time of this report we have been unable to determine if there was proper patient use of the device and if the device caused alleged burns due to the failure/hole/bursting of the packaging or from direct placement of the device on the skin.Investigation is somewhat hampered by information being supplied by the attorney for the patient.

Event Description

Woman's attorney described the event as; "please be advised that our client sustained serious burns to her lower back and buttocks area and is still under active medical care and it is anticipated that there will be permanent scarring but we will need to continue to monitor her healing process." product: dynarex cold pack, item #: 4512, lot: undetermined, not supplied as yet.

• Brand Name: DYNAREX INSTANT COLD PACK
• Type of Device: INSTANT COLD PACK
• Manufacturer (Section D): DYNAREX CORPORATION; 10 glenshaw street; orangeburg NY 10962 1207
• Manufacturer Contact: james hurlman ; 10 glenshaw street; orangeburg, NY 10962-1207 ; 8453658200
• MDR Report Key: 6223732
• MDR Text Key: 63915021
• Report Number: 2431014-2016-00002
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00616784451213
• UDI-Public: 616784451213
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4512
• Device Catalogue Number: 4512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention