MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEM; SYSTEM, THERMAL REGULATING

Catalog Number SWU-2003

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

Smiths medical has received the sample device and is currently being evaluated.The manufacturer will file a follow up report detailing the result of the evaluation once it is completed.

Event Description

This event occured in (b)(6).According to reporter, the device was in use for warming of patient during nasal surgery for an hour and 9 minutes.The reporter stated that after the surgery, the patient showed: reddened areas noted on chest, legs and primarily on abdomen where product had direct skin contact.No blisters noted but reddened areas on abdomen matched the functionality design of the blanket.Patient stated that he had no pain from the affected site during follow up in recovery room.No permanent adverse effects to patient reported.Unknown patient's condition at this time.

• Brand Name: LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEM
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana 55425 ; MX 55425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana 55425 ; MX 55425
• Manufacturer Contact: lisa perz ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5796502
• MDR Text Key: 49615892
• Report Number: 2183502-2016-01481
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: SWU-2003
• Device Lot Number: 3184607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR