MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ACCU-THERM HOT PACK (RED/WHITE PACKAGING) ; PACK, HOT OR COLD, DISPOSABLE

Model Number MDS138005

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 07/29/2019

Event Type  Injury  

Event Description

Radiology tech applied a medline instant hot pack to the pt's back for pain relief.Possible heat blister noted to pt's lower back in the day.Facility noticed a change in the medline packaging approx two months ago.It appears that medline changed the packaging of their product from maroon /yellow to red / white.The new red/white packaging appears to get hotter than the old maroon / yellow packs.A quick test with the temp gun showed the old maroon / yellow hot pack reached temps of 99 while the new red / white pack reached temps of 114-117 degrees f.

• Brand Name: ACCU-THERM HOT PACK (RED/WHITE PACKAGING)
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 8869246
• MDR Text Key: 153719829
• Report Number: MW5088857
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/01/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MDS138005
• Device Lot Number: CN18334
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 55