MAUDE Adverse Event Report: SMITH AND NEPHEW MEDICAL LTD. OPSITE IV 3000 DRSNG 4007; TAPE AND BANDAGE, ADHESIVE

Catalog Number IV 3000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Spontaneous call from patient who reported that her site has been in a lot of pain.She reported that it was red, swollen, and hard and she is very worried about it being infected.Patient actually went to urgent care today and she was turned away because she had not made an appointment.So far, she stated that she has only used "creams" for the site pain, tylenol, and applied aloe vera.She has reported site issues before but she plans on following up with her doctor's office tomorrow.Author reached out to (b)(6) nurse who called her and then responded back stating that patient might be experiencing an allergic reaction to iv3000 dressing.Her last site change was earlier this month.Patient is on subcutaneous remodulin therapy.No other information provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: OPSITE IV 3000 DRSNG 4007
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH AND NEPHEW MEDICAL LTD.
• MDR Report Key: 15438000
• MDR Text Key: 300160567
• Report Number: MW5112075
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2022

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: IV 3000
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2022
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female