MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PACK,COLD,STANDARD,OB-PAD,4.5X14.25

Catalog Number	MDS138055
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, "she used the pack at night and when she woke up the pack was leaking.Customer stated she folded the pack and placed in her underwear.When she woke up she noticed the issue." no additional information is available at this time.A sample has been requested for evaluation.Due diligence has been completed.No additional details are available related to the customer reported issue.Despite good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.It has been determined that the reported event could cause or contribute to serious injury requiring medical intervention, therefore, 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, "she used the pack at night and when she woke up the pack was leaking.Customer stated she folded the pack and placed in her underwear.When she woke up she noticed the issue.".

• Brand Name: MEDLINE
• Common Device Name: PACK,COLD,STANDARD,OB-PAD,4.5X14.25
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 25153426
• Report Number: 1417592-2026-01195
• Device Sequence Number: 21181315
• Product Code: IMD
• UDI-Device Identifier: 00080196733715
• UDI-Public: 00080196733715
• Combination Product (Y/N): N
• 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): 05/12/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDS138055
• Device Lot Number: VN25074
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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 Sex: Female