MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SNUGGLE WARM BLANKET; SYSTEM, THERMAL REGULATING

Catalog Number SWU-2003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

Distributor reported the upper body warming blanket was in use with patient along with a convective warmer set at 36 degree during procedure lasting approximately 30 minutes.After the procedure, burns were noticed on the patient's skin.The level of burns were reported to be of 1st or 2nd degree burns.No further intervention or adverse effects to patient reported.The convective warmer did not alarm and kept running during the entire procedure.

Manufacturer Narrative

The upper body blanket was received in its original open package.The sample was unfolded and visually inspected.A performance/functional test was performed and connected to an equator/blower.The device had all the seals in place, no delamination was detected an all the holes are present on the device.The performance/functional test demonstrated a good performance due to the blanket inflate/expand correctly, the holes let the warm air out without restrictions and the internal pressure meet the specification.The device and the investigation of the issue could not confirm the fault occurred.(b)(4).

• Brand Name: SNUGGLE WARM BLANKET
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 160 weymouth street; rockland MA 02370
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 160 weymouth street; rockland MA 02370
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5418693
• MDR Text Key: 37731229
• Report Number: 2183502-2016-00147
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2016

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 Expiration Date: 09/28/2018
• Device Catalogue Number: SWU-2003
• Device Lot Number: 3072608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR