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

Lot Number 400709

Device Problem Product Quality Problem (1506)

Patient Problems Erythema (1840); Swelling (2091)

Event Date 07/23/2019

Event Type  malfunction  

Event Description

Patient developed redness and blistering on hip after use.This item was a sub for another (other brands) product.The staff reported that this item was colder initially and stayed much colder for longer than other brand's products.Staff reported that after 5 min of use on themselves as a test that the coldness became "uncomfortable".

• Brand Name: ACCU-THERM INSTANT COLD PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9818437
• MDR Text Key: 182983353
• Report Number: 9818437
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/11/2020,07/30/2019

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: No Information
• Device Lot Number: 400709
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2020
• Date Report to Manufacturer: 03/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other