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 Zonular Dehiscence (2698)

Event Date 01/01/2018

Event Type  Injury  

Event Description

It was documented on the paper "prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial," that pico was being used in treatment for 876 patients and a minor wound dehiscence was reported.It is unknown if a treatment was performed or how the event was resolved.

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.A complaint history review was carried out across all pico products.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.It is recommended that dressings are 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: a review of the provided journal article "prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomized clinical trial" author: n hyldig et al., published in 2018.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.However, the patient¿s history of obesity cannot be ruled out as a contributing factor to the dehiscence.The root cause of the dehiscence and/or patient outcome could not be confirmed nor concluded.No further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.As the product code is unknown, a review of the device labelling could not be carried out.The risk files for pico contain multiple failure modes leading to wound dehiscence caused by poor technique or timing of dressing removal and changes.Without further information an exact failure mode cannot be determined.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 + nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + 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: 10268710
• MDR Text Key: 198716833
• Report Number: 8043484-2020-01987
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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: 11/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other