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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous.Patient reported these cleos and opsite are not sticking correctly and they keep falling out even after a complete cleaning the surface and changing the site.No missed dose or adverse event reported.Unknown if available for return.No further info.Reported to cvs/caremark by pt/caregiver.

• Brand Name: OPTISTE IV 3000 DRSNG 4007
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH AND NEPHEW MEDICAL LTD.
• MDR Report Key: 18493985
• MDR Text Key: 332910705
• Report Number: MW5150141
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2024
• Patient Sequence Number: 1
• Treatment: ADCIRCA; INF SET CLEO 24" 9MM; LIDOCAINE/PRILOCAINE CRM; PUMP CADD MS3 ; REMODULIN MDV; TRIAMCINOLONE ACET CRM
• Patient Sex: Male