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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW MEDICAL LTD. UNKN PRIMAPORE DRESSING,WOUND,OCCLUSIVE Back to Search Results
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.
 
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Brand NameUNKN PRIMAPORE
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer Contact
holly topping
101 hessle road
hull east riding of yorkshire HU3 2-BN
UK   HU3 2BN
5123913905
MDR Report Key11593229
MDR Text Key243066052
Report Number8043484-2021-00713
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
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 Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKN05005100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/30/2021 Patient Sequence Number: 1
Treatment
-REMODULIN SQ REGIMEN. DOSE, FREQUENCY & ROUTE USE
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