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

Catalog Number 8001061540

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

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 05/01/2019

Event Type  Injury  

Event 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.

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 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
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8675272
• MDR Text Key: 147228569
• Report Number: 0001831750-2019-00582
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07613327175073
• UDI-Public: 07613327175073
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Catalogue Number: 8001061540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/06/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1