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

Model Number	MDS139008
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Instant hot pack placed to left forearm, blisters noted by staff upon removal.Manufacturer response for pack, hot or cold, disposable, medline (per site reporter).Central supply has notified manufacturer.

• Brand Name: MEDLINE
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 18796137
• Report Number: 18796137
• Device Sequence Number: 12541589
• Product Code: IMD
• UDI-Device Identifier: 10888277320543
• UDI-Public: (01)10888277320543
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/21/2024
• Report Date (Section F): 02/21/2024

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 Model Number: MDS139008
• Device Catalogue Number: MDS139008
• Device Lot Number: VN23307-1314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 02/21/2024