MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PACK,COLD,INSTANT,STANDARD,6"X9"

Catalog Number	MDS137000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Burn(s) (1757); Chills (2191)
Date of Event	03/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer via phone call, on (b)(6), the user bumped her left arm and used the pack.The burn was on left arm about 4 inches and thick.The user stated it was sausage sized.The user went to urgent care and it seemed to be getting worse.They did an x-ray which showed the burn went underneath the skin.But then suggested to go to the hospital.Was seen in the ed who said it was a chemical burn from the ice pack.The hospital er said clean it off with cold water, no ice, and use vaseline.The user clarified she was not admitted to the hospital and was seen in the ed and discharged from the ed.Her arm hurts but there is no bend.After speaking to her pcp, the user went to the dermatologist who prescribed antibiotics (doxycycline and mupirocin ointment 2%) and wrapped it.Movement is limited stiff by elbow.The user said there was a leak from the pack and didn't realize at the time when it occurred.She said she is still not feeling well and has chills.The user stated that this is not life threatening.The sample is not available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer via phone call, on (b)(6), the user bumped left arm and used the pack.The burn was on left arm about 4 inches and thick.

• Brand Name: MEDLINE
• Common Device Name: PACK,COLD,INSTANT,STANDARD,6"X9"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25008908
• Report Number: 1417592-2026-00635
• Device Sequence Number: 10140147
• Product Code: IMD
• UDI-Device Identifier: 00080196732336
• UDI-Public: 00080196732336
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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?: No
• Device Catalogue Number: MDS137000
• Device Lot Number: 04324120001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 68 KG