MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEMS; SYSTEM, THERMAL REGULATING

Catalog Number SWU-2001

Device Problem Temperature Problem (3022)

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Information was received indicating that upon removal of a smiths medical level 1® snuggle warm® blanket erythema was noted to the patient's arm, forearm, chest and abdomen.The right forearm was reported to show the beginning of phlycten.The clinician stated that the patient was well positioned on the blanket without any external constraint.The warmer was reported to set to 44 degrees celsius but the display had read 37 degrees celsius.Subsequently, biafine was prescribed for dressings.There were no further reported adverse effects.

• Brand Name: LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEMS
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 8848545
• MDR Text Key: 152863861
• Report Number: 3012307300-2019-03893
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 10610586043321
• UDI-Public: 10610586043321
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/31/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: SWU-2001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention