MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BLKT 1-SIDE NONWOV COLDER CON; SYSTEM, THERMAL REGULATING

Catalog Number	8001061610
Health Effect - Clinical Codes	Swelling (2091); Tissue Damage (2104)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient allegedly suffered some skin damage and / or blisters while using a temperature therapy blanket the customer described the device that was being used with the blanket as a meditherm, however they could not verify this as they did not provide a serial number.
Additional Manufacturer Narrative
Additional attempts were made to gather further information regarding this alleged issue, however, the customer did not respond to these attempts.Further information was not available.
Event or Problem Description
It was reported that the patient allegedly suffered some skin damage and / or blisters while using a temperature therapy blanket the customer described the device that was being used with the blanket as a meditherm, however they could not verify this as they did not provide a serial number.

• Brand Name: BLKT 1-SIDE NONWOV COLDER CON
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 8414331
• Report Number: 0001831750-2019-00279
• Device Sequence Number: 16624352
• Product Code: DWJ
• UDI-Device Identifier: 07613327175127
• UDI-Public: 07613327175127
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/16/2019

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: 8001061610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1