MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BLKT 1-SIDE NONWOV COLDER CON; SYSTEM, THERMAL REGULATING

Catalog Number	8001061610
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a new altrix blanket was applied to a patient and it was leaking water from a small hole.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
After investigation, the cause for the altrix blanket leaking water from a small hole could not be confirmed as the device was not able to be evaluated.H3 other text : device was not accessible for evaluation.
Event or Problem Description
It was reported that a new altrix blanket was applied to a patient and it was leaking water from a small hole.The patient was not adversely affected and no clinically relevant delay in treatment was reported.

• Brand Name: BLKT 1-SIDE NONWOV COLDER CON
• 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: 17436379
• Report Number: 0001831750-2023-00969
• Device Sequence Number: 17844633
• Product Code: DWJ
• UDI-Device Identifier: 57613327175122
• UDI-Public: 57613327175122
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: 8001061610
• Device Lot Number: 3100A4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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