MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE IV 3000 DRSNG #4008; TAPE AND BANDAGE, ADHESIVE

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

Patient Problems Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Pt reported being hospitalized from (b)(6) 2022 due to an unspecified infection.Pt has been changing their dressings multiple times a day and noticed their skin was getting very irritated.Pt returned to the er yesterday (b)(6) 2022 and was advised to use an alternate dressing (other than opsite iv 3000 dressing #4008).Pt stated that the er provider put gauze and medical tape over the affected area for now and they appear to be tolerating that without any problems.Pt never had any issues with opsite iv dressings until now.Unknown if md is aware.No other information, details or dates provided.Reported to (b)(6) by pt caregiver.

• Brand Name: OPSITE IV 3000 DRSNG #4008
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.
• MDR Report Key: 14623857
• MDR Text Key: 293648767
• Report Number: MW5110154
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female