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

Model Number	8001-061-810
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hyper/hypo cooling/warming blanket begins to leak while in patient use.The blanket is not leaking from the connection site, but rather appears to have holes in the main blanket material.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
The customer did not make the product available for evaluation.Device not accessible for evaluation.
Event or Problem Description
It was reported that the hyper/hypo cooling/warming blanket begins to leak while in patient use.The blanket is not leaking from the connection site, but rather appears to have holes in the main blanket material.The patient was not adversely affected and no clinically relevant delay in treatment was reported.

• Brand Name: BLKT 1-SIDE NONWOV W/CLIK TITE
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10614049
• Report Number: 0001831750-2020-00918
• Device Sequence Number: 11060944
• Product Code: DWJ
• UDI-Device Identifier: 07613327175066
• UDI-Public: 07613327175066
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 12/17/2020

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: No Information
• Device Model Number: 8001-061-810
• Device Catalogue Number: 8001061810
• Device Lot Number: 1120B5
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1