MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE IV3000 SINGLE SHEET; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Irritation (2076)

Event Date 01/22/2015

Event Type  Injury  

Manufacturer Narrative

As there has not been a sample returned a full and detailed product assessment / physical investigation has not been possible.Further to this it has not been possible to review the batch manufacturing records as there has not been a product lot number provided on this occasion.Based on the available information and without the reported product no conclusive assessment regarding the reported is possible.

Event Description

It was reported by united therapeutics that a patient alleges adverse reaction while using opsite iv 3000 in combination of their product, remodulin.Patient reported to her speciality pharmacy that after receiving remodulin (treprostinil) via subcutaneous route for primary pulmornary hypertension, opsite iv 3000, and tegaderm, she began to experience redness and itching at the site.In addition, she reportedly experienced a headache as well.United therapeutics stated no additonal follow-ups will be made regarding this incident.All other parties involved are unknown.

• Brand Name: OPSITE IV3000 SINGLE SHEET
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping
• MDR Report Key: 10761561
• MDR Text Key: 213836591
• Report Number: 8043484-2015-00010
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

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: No Information
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 10/30/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 61