MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN APPLICA IV100; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKN05000600

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

Patient Problem Pressure Sores (2326)

Event Date 04/30/2021

Event Type  Injury  

Event Description

It was reported that, was conducted a retrospective post market clinical follow up activity (pmcf) on the use of applica iv100.In which, one patient treated with treated reported light pressure sores.This adverse event was treated with topical care with dexpanthenol.This data collection activity had been done retrospectively and anonymously; therefore, the outcome of the patient is unknown.No further information is available.

Manufacturer Narrative

H10: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include application and skin preparation and time left on patient.No lot/serial number has been provided, therefore a review is not possible.A complaint history review found other related events.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.H6: updated codes.

• Brand Name: UNKN APPLICA IV100
• 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
• MDR Report Key: 11846634
• MDR Text Key: 251346693
• Report Number: 8043484-2021-01161
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05000600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention