MAUDE Adverse Event Report: STRYKER CORPORATION STRYKER T PUMP/ PAD K PAD; PACK, HOT OR COLD, WATER CIRCULATING

Model Number TP700

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/01/2023

Event Type  malfunction  

Event Description

Upon examination of patient's skin partial thickness injury to bilateral thighs and right lateral buttock was found.The wounds were consistent with the pattern of the k pad (stryker t pump pad) heating pad that the patient had reported using.

• Brand Name: STRYKER T PUMP/ PAD K PAD
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): STRYKER CORPORATION
• MDR Report Key: 16598024
• MDR Text Key: 311960354
• Report Number: MW5115927
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TP700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White