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

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

Patient Problem Insufficient Information (4580)

Event Date 05/09/2021

Event Type  Injury  

Event Description

It was reported that on literature review "decreasing complications of pectoralis major muscle flap reconstruction with two modalities of negative pressure wound therapy," of 24 patient's treated with pico after a pectoralis major muscle flap surgery due to deep sternal wound infection, 1 patient required another flap.It is unknown the reason and the patient's outcome.Further information is unavailable.

Manufacturer Narrative

Section h10: it was reported that on literature review "decreasing complications of pectoralis major muscle flap reconstruction with two modalities of negative pressure wound therapy", of 24 patient's treated with pico after a pectoralis major muscle flap surgery due to deep sternal wound infection, 1 patient required another flap.It is unknown the reason and the patient's outcome.Further information is unavailable.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.As no lot number was provided it was not possible to carry out a device history review.A complaint history review revealed no similar instances in the last 12 months.A risk management review concluded that there is insufficient information within the complaint to determine the specific type of complication that occurred and/or to provide a causal link between the events and the product therefore a review of the risk management file in relation to this event cannot be performed and no updates to the risk files are required at this time.A clinical review concluded without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Without further information it is difficult to determine a probable root cause, however it is possible that the dressing has not been applied correctly or dressing not changed frequently enough and in accordance with the ifu.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct dressing application technique and frequency of dressing changes.This investigation is now complete, with no corrective actions required.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.Internal complaint reference number: (b)(4).

• Brand Name: UNKN PICO
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 14323705
• MDR Text Key: 291227273
• Report Number: 8043484-2022-00161
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention