MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SINGLE UNIT PACKAGING FOR 8001-061-810; SYSTEM, THERMAL REGULATING

Catalog Number	8001061810
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the customer alleged they had an issue with the item bursting.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
It is unknown if the product met specifications as the product was not returned for evaluation.

• Brand Name: SINGLE UNIT PACKAGING FOR 8001-061-810
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 21862245
• Report Number: 0001831750-2025-00348
• Device Sequence Number: 4606735
• Product Code: DWJ
• UDI-Device Identifier: 57613327175061
• UDI-Public: (01)57613327175061(10)552126
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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 Catalogue Number: 8001061810
• Device Lot Number: 552126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown