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

Catalog Number UNKN05003901

Device Problem Biocompatibility (2886)

Patient Problems Cellulitis (1768); Pain (1994); Contact Dermatitis (4546)

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that, on (b)(6) 2024, a patient began therapy with sq remodulin to treat a primary pulmonary arterial hypertension.On an unknown date in feb-2024, the patient was hospitalized for two weeks due to a subcutaneous infection (cellulitis at the infusion site) and patient though she was allergic to opsite iv 3000 (dermatitis contact).Since then, she had not been handling the site pain (infusion site pain) and wanted to come off the remodulin.At the time of reporting, the outcome of infusion site cellulitis and dermatitis contact was unknown, and the outcome of infusion site pain was not resolved.No further information is available.

• Brand Name: UNKN IV3000
• 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
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19138647
• MDR Text Key: 340566626
• Report Number: 8043484-2024-00037
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

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 Catalogue Number: UNKN05003901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: - VITAMIN C (ASCORBIC ACID)- AMLODIPINE BESYLATE
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 112 KG