MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN PICO 7; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number UNKNOWN

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

Patient Problems Itching Sensation (1943); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after using pico 7, when removing the dressing the skin from the patient's skin peeled, similar as sun peeling due to sunburn.Patient also reported that when she started using the device, she felt itchy and since the removal of the dressing the itching decreased.No additional information is available.

Manufacturer Narrative

As no lot number was provided, a review of the device history records was not possible.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.It was reported that when the dressing was removed, the patient had blisters where the dressing had been.Probable root causes include allergic reaction by the patient to one of the components of the dressing, an existing skin disorder or incorrect application or removal of the dressing.A medical review concluded that the information provided was insufficient to determine whether the patient¿s symptoms, signs or outcome were due to a pre-existing or concurrent medical procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.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.The medical review could not establish a link between the product and harm within this complaint and therefore additional rmr is not required.The user risk assessment for the device provides details of possible sensitisation reactions and irritation or irritants contact dermatitis, as possible harms caused by toxicology of the materials used in the dressing.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 7
• 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: 11510033
• MDR Text Key: 240555861
• Report Number: 8043484-2021-00648
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other