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

Model Number	8001-061-535
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Blister (4537)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient developed blisters caused by the wraparound wraps.No information has been provided regarding the severity or treatment of the injury.Attempts have been made to reach the customer for more information, however they have not responded to these attempts.
Event or Problem Description
It was reported that a patient developed blisters caused by the raprround wraps.No information has been provided regarding the severity or treatment of the injury.Multiple attempts have been made to reach the customer for more information, however they have not responded to these attempts.
Additional Manufacturer Narrative
The device was not evaluated and no cause was determined as the customer did not make the device accessible for testing.The customer did not respond to requests for additional information regarding the injury, but should we receive more information a supplemental will be filed.The investigation is complete.B5 and h codes updated to match investigation results.

• Brand Name: LG VEST 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: 11055158
• Report Number: 0001831750-2020-01224
• Device Sequence Number: 4241244
• Product Code: DWJ
• UDI-Device Identifier: 07613327175103
• UDI-Public: 07613327175103
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K100585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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 Model Number: 8001-061-535
• Device Catalogue Number: 8001061535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other