MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 14 15X15CM CTN1; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802045

Device Problems Leak/Splash (1354); Physical Resistance/Sticking (4012)

Patient Problems Pain (1994); Skin Tears (2516)

Event Date 05/19/2021

Event Type  Injury  

Event Description

It was reported that during npwt with pico 14 15x15cm, the dressing leaked.While changing the dressing, it had stuck to the patient's wound and surrounding skin, causing it to tear on the wound bed and pain to the patient.The problem was solved by rest and the dressing was removed by wetting it with normal saline.The patient recovered.

Manufacturer Narrative

The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review found a small number of similar instances of the reported event.There is nothing to indicate that this is outside of acceptable rates of occurrence.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.The medical review could not establish a link between the product and harm within this complaint.It was reported that the dressing leaked and stuck to the skin upon removal.Probable root causes include incorrect skin preparation, incorrect application or removal of dressings or infrequent dressing changes.The users of the reported product are advised to consult the ifu, to reduce future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including application and removal of dressings and frequency of changes.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.

• Brand Name: PICO 14 15X15CM CTN1
• 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: 11913651
• MDR Text Key: 253530080
• Report Number: 8043484-2021-01313
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K191760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2021
• Device Catalogue Number: 66802045
• Device Lot Number: 2010
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention