MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BLKT 1-SIDE NONWOV W/CLIK TITE; SYSTEM, THERMAL REGULATING

Catalog Number 8001061810

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that the device was spraying water from the blanket (liquid leaks onto the patient surface).No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: BLKT 1-SIDE NONWOV W/CLIK TITE
• Type of Device: 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19043746
• MDR Text Key: 339519957
• Report Number: 0001831750-2024-00353
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 57613327175061
• UDI-Public: 57613327175061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8001061810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1