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 Post Operative Wound Infection (2446)

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported that, on literature review "complications in oncologic mandible reconstruction: a comparative study between the osteocutaneous radial forearm and fibula free flap", 1 patient initially underwent a free fibula flap (fff) osteotomy for mandibular reconstruction following oncologic segmental resection.The wound at the donor site was treated with a skin graft and negative pressure wound therapy was applied using an unspecified pico pump during 5 days postoperatively.This patient experienced a wound infection that required debridement and further negative pressure wound therapy.The patient's outcome is unknown.No further information is available.

Manufacturer Narrative

It was reported that, on literature review "complications in oncologic mandible reconstruction: a comparative study between the osteocutaneous radial forearm and fibula free flap", 1 patient initially underwent a free fibula flap (fff) osteotomy for mandibular reconstruction following oncologic segmental resection.The wound at the donor site was treated with a skin graft and negative pressure wound therapy was applied using an unspecified pico pump during 5 days postoperatively.This patient experienced a wound infection that required debridement and further negative pressure wound therapy.The patient's outcome is unknown.No further information is available.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 the sequence of events described in this complaint are not contained in the relevant risk files.There is insufficient information within the complaint description and further information included in this complaint to provide a causal link between events and the product therefore no update to the risk files is warranted.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.Probable root cause is 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.

• 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: 14323662
• MDR Text Key: 291208195
• Report Number: 8043484-2022-00163
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention