MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ACCU-THERM HOT PACK COMPRESS PACK; PACK, HOT OR COLD, DISPOSABLE

Lot Number CN18289

Device Problem Material Rupture (1546)

Patient Problem Burn, Thermal (2530)

Event Date 01/19/2019

Event Type  malfunction  

Event Description

Veteran yelled out from room at 3:30pm.The hot pack he was about to apply to his shoulder burst in his lap.He has burns to his scrotum, penis and left thumb.Removed veterans clothing, washed off hot pack solution and granules with cool water.

• Brand Name: ACCU-THERM HOT PACK COMPRESS PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 8336451
• MDR Text Key: 136518493
• Report Number: MW5083979
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: CN18289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 63