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

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

Spontaneous.Pt reports opsite comes off and button falls out.No other information known.Pt did not miss a dose or experience and adverse event.Unknown product lot number.Pt does not have defective device on hand.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 & NEPHEW MEDICAL LTD.
• MDR Report Key: 12481528
• MDR Text Key: 272444054
• Report Number: MW5104012
• 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: 08/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1