MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO SINGLE USE NPWT 10 X 40CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800953

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

Patient Problems Skin Irritation (2076); Injury (2348)

Event Date 08/26/2019

Event Type  Injury  

Event Description

It was reported blistering of healthy skin under pico dressing and skin breakdown.The pico was used prophylactically in breast surgery.

Manufacturer Narrative

A relationship between the reported incident and the pico device could not be established as the sample was not returned for evaluation.A review of the batch manufacturing records could not performed as the lot number was not provided.Clinically relevant supporting documentation was not provided; therefore a thorough medical investigation could not be performed.However, the images provided were reviewed and confirmed the reported adverse skin reaction.As stated in the instructions for use for this product, dressings should be regularly monitored and typically changed every 3-4 days.Failure to do so may result in adverse events.Prior to manufacturing, all pico pumps undergo full functionality testing to an agreed specification.This ensures that all pumps are working correctly before being shipped to our customers; any failures identified are segregated for investigation.On this occasion we have been unable to determine a definitive root cause for the reported event.Therefore, no further action is deemed necessary.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: PICO SINGLE USE NPWT 10 X 40CM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9109080
• MDR Text Key: 159778956
• Report Number: 8043484-2019-00662
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

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
• Device Catalogue Number: 66800953
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/01/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 10/26/2019
• Supplement Dates FDA Received: 10/31/2019
• Patient Sequence Number: 1