MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; SYSTEM, THERMAL REGULATING

Catalog Number UNK_MED

Device Problems Patient Device Interaction Problem (4001); Excessive Heating (4030)

Patient Problems Abrasion (1689); Skin Discoloration (2074); Blister (4537)

Event Date 03/08/2021

Event Type  Injury  

Event Description

It was reported that the patient has skin abrasions on their back from the cooling blanket being placed underneath them.It was reported that the cooling blanket may have accidentally been programmed to warm the patient instead of cool them.Further information has not been provided.

Event Description

It was reported that the patient has skin abrasions on their back from the cooling blanket being placed underneath them.Upon further communication with the user facility it was reported that the patient had blisters/discolored skin as a result of the event and not abrasions.It was reported that the cooling blanket may have accidentally been programmed to warm the patient instead of cool them.

Manufacturer Narrative

It was initially reported that the patient has skin abrasions on their back from using the device.The customer confirmed that the patient actually had blisters/discolored skin and not abrasions.It was reported that venemax and xeroform was used to treat the injury.The model and lot number of the blanket could not be identified by the user facility.It was determined based on the information provided by the user facility that this issue was likely due to no defect with the blanket and was likely due to misuse of the blanket.The customer was provided feedback that the device and associated altrix functioned as intended and no defect was identified.H3 other text : device could not be identified.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11623543
• MDR Text Key: 244208656
• Report Number: 0001831750-2021-00673
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K152266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8001000001 ALTRIX, DOMESTIC
• Patient Outcome(s): Other