MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL, INC. MCKESSON MEDI-PAK; INSTANT HOT COMPRESS

Model Number 59-79H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Swelling (2091); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 01/04/2018

Event Type  malfunction  

Event Description

Activated mckesson hot compress instant deluxe was provided to the patient by laboratory tech in an effort to assist in blood draw.Hot compress was placed on patient's right volar forearm.After a couple minutes (exact time unknown but was not abnormally long) the pack was removed.According to staff the arm was flushed but did not appear abnormal and did not cause the patient pain.That night, hours after the procedure, the patient began to develop blisters and eventually skin necrosis during the next several days.Patient determined to have partial thickness or full-thickness to superficial partial thickness burn.Unfortunately this device was not retained.

• Brand Name: MCKESSON MEDI-PAK
• Type of Device: INSTANT HOT COMPRESS
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland dr # 4000; richmond VA 23233
• MDR Report Key: 8292365
• MDR Text Key: 134599098
• Report Number: 8292365
• 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: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 59-79H
• Device Catalogue Number: 59-79H
• Device Lot Number: POTENTIALLY CN 7053A1
• 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: 01/17/2019
• Event Location: Other
• Date Report to Manufacturer: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24455 DA