MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; PACK, HOT OR COLD, DISPOSABLE

Model Number 11443-512B

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)

Patient Problem Chemical Exposure (2570)

Event Date 02/25/2019

Event Type  malfunction  

Event Description

Rn was showing patient how to squeeze a heat pack.There are hand markers on the packs for where you are supposed to hold them.Rn did exactly as instructed and the contents of the heat pack shot out of the bag and hit the floor, the rn, and the patient's wife.She, the patient's wife, was wearing long pants and about a tablespoon of the contents of the bag landed on her leg.We immediately wiped it off and asked if she was ok and if she felt any heat on her leg.She said that she was fine and did not feel any heat.Rn could feel warmth on her hand but sustained no injury.

• Brand Name: CARDINAL HEALTH
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 8451391
• MDR Text Key: 139824783
• Report Number: 8451391
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11443-512B
• Device Catalogue Number: 11443-512B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2019
• Date Report to Manufacturer: 03/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1