MAUDE Adverse Event Report: Medline Industries, LP - SPT Medline; SKIN PACK II SS

Catalog Number	DYNJ55959F
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the corner of the bag gradually tore, resulting in the heart being recovered for research falling to the floor.
Additional Manufacturer Narrative
It was reported that the corner of the bag gradually tore, resulting in the heart being recovered for research falling to the floor.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Brand Name: Medline
• Common Device Name: SKIN PACK II SS
• Manufacturer (Section D): Medline Industries, LP - SPT; 1170 s northpoint boulevard; waukegan IL 60085 -675
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50216593
• Report Number: 1423395-2026-00491
• Device Sequence Number: 6122931
• Product Code: FMH
• UDI-Device Identifier: 10195327645991
• UDI-Public: 10195327645991
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: n/a
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: Health Professional
• Device Catalogue Number: DYNJ55959F
• Device Lot Number: 26DLA507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 318 LB
• Patient Race: White