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 Problems Impaired Healing (2378); Tissue Breakdown (2681)

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 was not satisfied with surrounding skin health.Skin was macerated by the product sticking too tightly.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

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.Medical review concluded, the root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.No further medical assessment is warranted at this time.Probable root cause may include preparation of wound area.No lot/serial number has been provided therefore a review of device history is not possible.Complaint history review found further instances, however, no further actions are deemed necessary at this time.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 11846590
• MDR Text Key: 251345577
• Report Number: 8043484-2021-01159
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

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 Operator: Health Professional
• Device Catalogue Number: UNKN05000600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention