MAUDE Adverse Event Report: JIANGSU INTCO MEDICAL PRODUCTS CO.LTD MCKESSON BRANDS; COMPRESS, HOT INST 6"X9" LF

Catalog Number 16-9707

Device Problem Use of Device Problem (1670)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 01/22/2022

Event Type  Injury  

Event Description

The customer reported that a newborn infant received blisters and second degree burn after the hot pack was placed directly on the right foot to dilate the vein for an iv start.The pack was on the foot for 1-2 minutes when the blisters occurred on (3) surfaces: foot, ankle, and heel surrounded by erythema.The pack was not wrapped in a cloth prior to application as indicated on the packaging.Burn wounds demonstrating signs of healing on current wound regimen.

• Brand Name: MCKESSON BRANDS
• Type of Device: COMPRESS, HOT INST 6"X9" LF
• Manufacturer (Section D): JIANGSU INTCO MEDICAL PRODUCTS CO.LTD; 77# yandunshan road; dagang zhenjiang, jiangsu 21213 2; CH 212132
• MDR Report Key: 15365615
• MDR Text Key: 299357168
• Report Number: 1451040-2022-00051
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-9707
• 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: 09/06/2022
• Distributor Facility Aware Date: 08/09/2022
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other