MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 14 15X20CM CTN1; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802046

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/09/2021

Event Type  Injury  

Event Description

It was reported that during treatment the wound pad was causing allergy, redness and pustules in the area, causing small new wounds, the patient had to be treated with an ointment containing cortisone to relieve the allergic reaction.

Manufacturer Narrative

H3, h6: we have now concluded our investigation for the complaint received.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 complaint history review found one further instance of the reported event.The associated risk files contain details relating to harm.The users of the reported product are advised to consult the device labelling/ifu, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device.A clinical investigation concluded: one undated photo of the wound was provided for review and confirms the reported redness around the wound.The information provided is insufficient to determine whether the patient¿s symptoms, are due to a pre-existing or concurrent medical or surgical condition or procedure.It cannot be definitively concluded that the root cause of the reported allergy, redness, and pustules is the direct result of using the pico dressing.It was communicated ointment was used to relieve the allergic reaction.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.The device, used for treatment, was not returned for evaluation.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 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 14 15X20CM 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: 11429964
• MDR Text Key: 238327771
• Report Number: 8043484-2021-00512
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66802046
• Device Lot Number: 1923
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention