MAUDE Adverse Event Report: MEDLINE INDUSTRIES; HOT PACK

Catalog Number MDS138005

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

The patient had originally been admitted for a norco overdose.The hot pack was placed directly on the patient's left hand by the tech who was sitting with him.There was no barrier between the patient's skin and hot pack.At some point the tech wrapped the hot pack directly to the patient's hand with an ace wrap.It is unclear why the hot pack was applied directly to the unprotected skin and then wrapped in place for an extended period of time.The next morning when the hot pack was removed, the patient had developed a second degree burn to the left hand.The hot pack was clearly labeled with "wrap in a cloth" and "do not place directly on skin".The contact acknowledged that the employee did not follow instructions indicated on the device.It has been determined that user error is the root cause for this incident.Due to the second degree burn that resulted, this medwatch is being filed.Device not returned.

Event Description

It was reported that a hot pack caused a burn to a patient's hand.

• Type of Device: HOT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES; one medline place; mundelein IL 60060
• Manufacturer Contact: megan debus ; one medline place; mundelein, IL 60060 ; 8477703962
• MDR Report Key: 6215557
• MDR Text Key: 63634963
• Report Number: 1417592-2016-00127
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2016

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: Medical Assistant
• Device Catalogue Number: MDS138005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/23/2016
• Initial Date FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR