MAUDE Adverse Event Report: SMITH MEDICAL SNUGGLE WARM PATIENT WARMING BLANKET

Catalog Number SWU2001

Device Problems Unknown (for use when the device problem is not known) (2204); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Skin Discoloration (2074)

Event Date 10/23/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, a (b)(6) y/o pt went to the operating room for a total left total hip arthroplasty, it is reported the surgery went well but when they operating room crew removed the warming blanket from top of the pt, there were small pale red spots on the pt's left forearm related to the body warmer.Spots were getting lighter in color upon arrival to the recovery room.Risk became aware of the event on (b)(6) 2017 at which time the warming unit was sequestered when discovered the unit used.Unfortunately the warming blanket was not saved.The delay in reporting the event is due to waiting to see if the warming blanket or warming unit required the med-watch.Risk had the warming unit checked to see if the unit was functioning properly.The warming unit was checked and found to be functioning in the parameters listed by biomed / manufacturer.Leaving the med-watch needed for the warming blanket.There is no documentation as to the redness in the pt's chart and the pt was discharged home on (b)(6) 2017.

Event Description

This was originally sent on 11/15/2017 but returned unopened to risk management on 12/05/2017.Found the correct address for smith medical from our central stores department and resending this to the correct address.Originally sent to smith medical asd, inc.In (b)(4).

• Brand Name: SNUGGLE WARM PATIENT WARMING BLANKET
• Type of Device: WARMING BLANKET
• Manufacturer (Section D): SMITH MEDICAL; po box 8500; philadelphia PA 19178 5155
• MDR Report Key: 7071930
• MDR Text Key: 93483510
• Report Number: 7071930
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SWU2001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2017
• Distributor Facility Aware Date: 10/23/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR