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

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

Patient Problem Burn(s) (1757)

Event Date 08/19/2020

Event Type  Injury  

Event Description

It was reported that he patient's daughter called in reporting that her mother had surgery on her ankle and had a pico 7 placed with a boot over it.She stated that over the evening she had trouble sleeping as her leg was burning, she also stated that the orange light stating the dressing is full is showing.No further information provided.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no part number was provided and the lot provided is not a valid lot number for this product, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out using the part number provided, there have been further complaints reported with this failure mode in the past three years.The device was used in treatment.As no samples were returned a product evaluation could not be carried out.The dressing full lamp may also indicate blockages.If the tubing becomes trapped under clothing, this may affect the delivery of successful negative pressure wound therapy.A clinical investigation concluded; ¿it has been communicated via the product complaint form that ¿no further information available.¿ no relevant supporting clinical information was provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.¿ a risk management review was carried out which identified some potential causes for the reported issue.The risk files for this product contains the failure mode of dressing not changed after becoming full.This can lead to multiple harms such as delayed wound healing, maceration and local infection.Without further information as to the cause and harm in this complaint a thorough review cannot be carried out.As stated in the ifu for this product, prolonged placement of rigid or opaque materials over the pico dressing may prevent the regular inspection and assessment of the wound, and disrupt scheduled or required dressing changes.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: UNKN PICO 7
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10525254
• MDR Text Key: 206706627
• Report Number: 8043484-2020-02852
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention