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

Catalog Number	8001061540
Health Effect - Clinical Codes	Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was alleged that a patient developed blisters on their back.The customer alleges that the patient required wound care consult and was treated.It was reported that the patient was post cardiac arrest and on the targeted temperature management protocol.
Additional Manufacturer Narrative
It was reported by the user facility that this complaint was documented "around christmas 2018." it was reported that a male patient had been using the wrap during a targeted temperature management protocol following cardiac arrest and developed blisters on his back.Allegedly the patient had required a woc consult and was treated.No further information was provided regarding the treatment, therapy specifications, duration, patient condition, or other potential contributing factors.In response,attempts were made to gather further information regarding this alleged issue, however, the customer did not respond to these attempts.Device not returned.
Event or Problem Description
It was alleged that a patient developed blisters on their back.The customer alleges that the patient required wound care consult and was treated.It was reported that the patient was post cardiac arrest and on the targeted temperature management protocol.

• Brand Name: LEG WRAP BLKT ASSY CLIK TITE
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 8675272
• Report Number: 0001831750-2019-00582
• Device Sequence Number: 2510794
• Product Code: DWJ
• UDI-Device Identifier: 07613327175073
• UDI-Public: 07613327175073
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 8001061540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1