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

Catalog Number UNKN05004900

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

Patient Problem Skin Tears (2516)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that the aim of the study was to assess the feasibility of a definitive randomized trial (rct) to test the effectiveness and safety of prophylactic npwt in obese women after cesarean.Obese women (bmi 30kg/m2) undergoing cesarean were randomly assigned to either prophylactic npwt with the pico device (smith& nephew) or standard dressing.The pico was removed at discharge (usually on day 4).There were 2 cases of skin separation in the npwt group.

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 or lot numbers were provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains further instances related events of the reported events.The device was intended for use in treatment.As no samples were returned, a product evaluation could not be carried out.Dressings should be changed around every 3 days but in some cases may be left in place for 7 days.If the adhesive integrity is compromised due to prolonged wear, the surgical site may be susceptible to external contamination.¿a clinical investigation concluded; the data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.As the product code is unknown, a review of the device labelling could not be carried out.The associated risk file contains the reported event.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
• 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: 10274036
• MDR Text Key: 198859567
• Report Number: 8043484-2020-02030
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other