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 No Code Available (3191)

Event Date 06/29/2020

Event Type  Injury  

Event Description

It was reported that the aim of the study was to asses if the use of an inpwt device would contribute to improved wound appearance and decreased wound complication rates compared with traditional incision management.185 patients received an inpwt device, including 57 tha and 128 tka patients.213 patients received a standard of care dressing, including 50 tha and 163 tka patients.In the inpwt group a patient was prescribed antibiotics.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: 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 device was intended for use in treatment.As no sample was 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; based on the literature review, ¿incisional negative pressure wound therapy devices improve short-term wound complications, but not long-term infection rate following hip and knee arthroplasty,¿ wound healing problems and deep infection occur infrequently following elective lower extremity joint arthroplasty but can have devastating consequences for the minority of patients affected.The aim of the study was to compare the effects of an inpwt device and a soc conventional postoperative wound dressing on early wound healing, wound complications, and late infection rates for patients undergoing hip and knee tja.During the studying it was reported that the patients in the inpwt group were prescribed antibiotics.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.Should information become available this complaint can be re-assessed.As the product code is unknown, a review of the device labelling could not be carried out.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: 10293152
• MDR Text Key: 199446187
• Report Number: 8043484-2020-02090
• 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,user f
• 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: 07/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention