MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LEG WRAP BLKT ASSY COLDER CONN; SYSTEM, THERMAL REGULATING

Catalog Number	8001061640
Health Effect - Clinical Code	Swelling (2091)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after using the device, blisters appeared on the lower leg of the patient.Further information has not been provided.
Additional Manufacturer Narrative
It was reported that blisters appeared on the leg after use.Communication with a clinical science liaison identified that this was most likely a pressure injury caused in part by the patient's congestion edema.It was identified that the patient/blanket interface pressure being too high was not due to a defect with the wrap itself, and was most likely attributed to use error and the patient's medical condition.This issue was resolved for the customer by connecting the customer with clinical staff to provide feedback on device use.Device not returned.
Event or Problem Description
It was reported that after using the device, blisters appeared on the lower leg of the patient.Further information has not been provided.

• Brand Name: LEG WRAP BLKT ASSY COLDER CONN
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 8680040
• Report Number: 0001831750-2019-00585
• Device Sequence Number: 16697361
• Product Code: DWJ
• UDI-Device Identifier: 07613327261387
• UDI-Public: 07613327261387
• Combination Product (Y/N): N
• PMA/510(K) Number: K152266
• 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): 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 8001061640
• Device Lot Number: 0386C5
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1