MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN PICO 14

Catalog Number UNKN05004904

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

Patient Problem Swelling/ Edema (4577)

Event Date 05/06/2021

Event Type  Injury  

Event Description

It was reported that during nwpt using pico 14, the patient's medial aspect of his left knee is a "little puffy" and the wound vac has zero drainage.The reporter stated that she can see the suctioning motion and that the patient can see and also feel the suctioning motion.The reporter said that the pump is correctly working and it was confirmed that only the ok green light is flashing.In addition, the patient's surgeon placed tegaderm entirely over the entire dressing pad, not on the edges.The reporter questioned whether the dressing needs changing, as it feels that the tegaderm is all affecting the functionality of the device since it's preventing the 80% of the evaporation function of the pico 14 dressing.A competitors device was used as additional to the smith and nephew device.A swelling in knee patient was reported, it unknown hot it was treated.

Manufacturer Narrative

Additional information: a2.H3, h6: as no lot number was provided, a review of the device history records was not possible.A complaint history review revealed no similar instances of the reported event.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.It was reported that when the dressing was suctioning and there were no warning lights illuminated, only the green light, but that the patients surgeon had placed a tegaderm over the dressing which was preventing the absorption of exudate.The probable root cause of the issue is an error in use by the hcp, as the placing of the tegaderm was preventing evaporation thus affecting absorption by the dressing.The users of the reported product are advised to consult the ifu, to delineate 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.As the event did not report any significant non-transient harm, no medical or risk management review is required in this case.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 14
• Type of Device: UNKN PICO 14
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11881900
• MDR Text Key: 252645374
• Report Number: 8043484-2021-01206
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR