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

Catalog Number UNKNOWN

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

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

In the paper: "outcomes of incisional negative pressure wound therapy following brachiobasilic transposition arteriovenous fistula creation: a 1:2 propensity score matched study".The authors of the study reported that a patient under the opsite treatment needed admission or readmission to hospitalization.It is unknown how the patient was treated.

Manufacturer Narrative

The device that was used in treatment was not returned for evaluation, with no additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Details surrounding the patient¿s resubmission to the hospital were not provided.Infections are potentially inherent to any surgical procedure.A review of the manufacturing records could not be performed because the lot number was not provided.A complaint history review found other related failures.Risk management files contain the reported failure mode.No update required.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.A clinical/medical assessment was performed and determined no further actions are required.Smith and nephew will continue to monitor for any adverse trends relating to this product.

• Brand Name: UNKN OPSITE
• 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: 10786010
• MDR Text Key: 214581085
• Report Number: 8043484-2020-03710
• 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: foreign,literature,study
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/04/2021
• Patient Sequence Number: 1