MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SMITH & NEPHEW PICO 7; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 18994895 27513B

Device Problem Overheating of Device (1437)

Patient Problems Pain (1994); Burning Sensation (2146); Blister (4537)

Event Date 05/31/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, a pico single use npwt device was applied to the patient's right knee wound by a nurse.The dressing was placed over the wound, and the pump was secured to the right lateral leg.On that same day, the patient called complaining of pain in her right lateral leg where the pump was located, and the nurse told her to disconnect/remove the pump if the pain was bad.The patient called back and stated that the pump felt very hot, and that she was experiencing a burning feeling in her right lateral leg.The nurse told her again to disconnect/remove the pump, which she did.The patient noticed two red marks in the area where the pump had been.At her follow-up appointments on (b)(6) 2022, blisters were noted in the area.Fda safety report id# (b)(4).

• Brand Name: SMITH & NEPHEW PICO 7
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.
• MDR Report Key: 14695398
• MDR Text Key: 294159658
• Report Number: MW5110316
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 18994895 27513B
• Device Catalogue Number: UTD66022002
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: Native Hawaiian Or Other Pacific Islander