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

Catalog Number 66801361

Device Problem Patient Data Problem (3197)

Patient Problem Skin Irritation (2076)

Event Date 08/18/2019

Event Type  malfunction  

Event Description

It was reported that the patient went to the hospital to washing, debridement and cleaning.After that the device was applied.The next day, the patient presents itch, skin redness and bumps on the upper part of the wound where the dressing was placed.The physician removed the dressing, cleaned the patient's wound and applied antibiotic on the skin.After this, the symptoms stopped.The device was disposed of after the incident.

Manufacturer Narrative

We have now completed our investigation into the reported complaint.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaints history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this issue in the past four years.The device was used for treatment in which pain and itching was experienced.No samples were received for this complaint therefore visual inspection and functional evaluation could not be performed.As no images were provided of the reported adverse skin reaction, a clinical assessment of the root cause could not be rendered.Prior to distribution, 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.A healthcare professional must be contacted in the first instance is pain or reddening is experienced so that the appropriate steps can be taken to rectify an adverse reaction.We have been unable to confirm the failure mode and subsequently identify a root cause on this occasion.We have been unable to confirm a relationship between the reported event and the device.Should further information become available this case may be reopened.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: PICO WITH SOFT PORT 15X15CM
• 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: 9380441
• MDR Text Key: 168470996
• Report Number: 8043484-2019-00863
• 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
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 66801361
• Device Lot Number: 1837
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 109