MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN OPSITE; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKN05004800

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Rash (2033); Urticaria (2278)

Event Date 12/19/2020

Event Type  Injury  

Event Description

It was reported that, patient began therapy with remodulin (treprostinil sodium, concentration of 2.5 mg/ml), on (b)(6) 2016 for primary pulmonary arterial hypertension.The current dose was reported as 0.074 ¿g/kg, continuous via intravenous (iv) route.On (b)(6) 2020, 4 years 5 months 27 days after initiating iv remodulin, the patient had been off iv remodulin for at least 2 hours as temporary central line repair came apart, so she clamped her line and covered with gauze and paper tape en route to emergency department.Later, the pharmacist at hospital confirmed that the patient was admitted for central line exchange.At the time of report, the patient was on peripheral iv remodulin, and was awaiting central line replacement.Follow-up information on 29 dec 2020, via accredo specialty pharmacy: on an unreported date, the patient experienced event of some skin irritation around new central line site (injection site irritation).It was reported that, the patient had some skin irritation around new central line site.Action taken with iv remodulin was not reported for the event of injection site irritation.At the time of reporting, the outcome of injection site irritation was unknown.The reporter did not provide causality for the event of injection site irritation.Follow-up information on 13 jan 2021, via accredo specialty pharmacy: on an unreported date, the patient experienced the event of swelling around stitches from central line replacement; swelling around cvl stitches (injection site swelling).It was reported that the patient had swelling around stitches from central line replacement.Action taken with iv remodulin was not reported for the event of injection site swelling.At the time of reporting, the outcome of injection site swelling was unknown.The reporter did not provide causality for the event of injection site swelling.The reporter assessed the causal relationship between the iv remodulin, and the event of dermatitis contact as not related.Follow-up information on 05 feb 2021, via accredo specialty pharmacy: on an unreported date, the patient experienced events of rash and hives around central line site (injection site rash and injection site urticaria).It was reported that, since the patient¿s last central line replacement had a rash and now hives around the central line site (at the time of reporting).Action taken with iv remodulin was not reported for the events of injection site rash and injection site urticaria.At the time of reporting, the outcome of event injection site rash was unknown and outcome of event injection site urticaria was considered not resolved.The reporter did not provide causality for the events of injection site rash and injection site urticaria.Follow-up information on 10 feb 2021, via accredo specialty pharmacy: it was reported that the patient had an allergic reaction to opsite dressing (dermatitis contact previously reported).Action taken with opsite was not reported for the events of dermatitis contact, injection site irritation, injection site swelling, injection site rash, and injection site urticaria.It is unknown how was the treatment finished and if there was a delay.No other complications where reported.

Manufacturer Narrative

We have now concluded our investigation into the reported complaint.As not batch/lot numbers have not been provided, it has not been possible to carry out a device history review.As no specific product details have been provided, it has not been possible to carry out a comprehensive complaint history review.Event occurred during patient treatment.The device intended for use in treatment was not returned for evaluation, therefore no functional evaluation could not be carried out.It has not been possible to establish the root cause of the issue.We have not been able to establish a relationship between the reported event and the device.A clinical review was carried out which determined that the information provided is insufficient to determine whether the patient¿s symptoms were due to a pre-existing or concurrent medical condition (allergy history, skin/dermal sensitivities) or a non allergic irritation caused by one or more of the components in the product.Additionally, it was reported the hospital will not perform any further follow-up for this event.Therefore, the impact to the patient beyond that which has already reported cannot be determined.As the medical review could not establish a definitive link between the product and harm within this complaint, it is determined that an additional risk management review is not required.The instructions for use for the product provides comprehensive instructions of the operation, use and limitations of the device.The investigation has been closed.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 OPSITE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11500357
• MDR Text Key: 240358879
• Report Number: 8043484-2021-00639
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REMODULIN IV (TREPROSTINIL SODIUM) INJECTION, 2.; REMODULIN IV (TREPROSTINIL SODIUM) INJECTION, 2.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 85