MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN PRIMAPORE; DRESSING,WOUND,OCCLUSIVE

Catalog Number UNKN05005100

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

Patient Problems Erythema (1840); Itching Sensation (1943); Blister (4537)

Event Date 03/05/2021

Event Type  Injury  

Event Description

It was reported that, patient began therapy with remodulin (treprostinil sodium, concentration 10 mg/ml), on (b)(6) 2019 for primary pulmonary arterial hypertension.Current dose was reported as 0.138 ¿g/kg, continuous via subcutaneous (sq) route.On an unreported date, the patient experienced event of subcutaneous remodulin site was red and itchy (infusion site erythema and infusion site pruritus).Action taken with sq remodulin was not reported for the events of infusion site erythema and infusion site pruritus.At the time of reporting, the outcome of events infusion site erythema and infusion site pruritus was unknown.The reporter did not provide causality for the events of infusion site erythema and infusion site pruritus.Follow up information was received on 01 mar 2021 from a consumer via (b)(6): on an unreported date, the patient had skin irritation under subcutaneous remodulin insertion site dressings, reports skin itching and blistering with mepilex and primapore dressings, less irritation with iv 3000 (dermatitis contact).Co-suspect medication included: mepilex (silicon), primapore and iv 3000 for dressing topically.It was reported that the patient had skin irritation under subcutaneous remodulin insertion site dressings.She had skin itching and blistering with mepilex and primapore dressings and less irritation with iv 3000.Action taken with sq remodulin, mepilex, primapore and iv 3000 was not reported for the event of dermatitis contact.Action taken with mepilex, primapore and iv 3000 was not reported for the events of infusion site erythema and infusion site pruritus.At the time of reporting, the outcome for the event of dermatitis contact was unknown.The reporter did not provide causality for the event of dermatitis contact.It is unknown how was the treatment completed and if there was a delay.No other complications were reported.

Manufacturer Narrative

The device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.Probable root cause is application, removal, time left on patient, trauma, materials used within the dressing.No lot/serial number has been provided, therefore a review is not possible.Complaint history review found other related events.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: UNKN PRIMAPORE
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11593229
• MDR Text Key: 243066052
• Report Number: 8043484-2021-00713
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05005100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: -REMODULIN SQ REGIMEN. DOSE, FREQUENCY & ROUTE USE; -REMODULIN SQ REGIMEN. DOSE, FREQUENCY & ROUTE USE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75