MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. HYDROSITE AD PLUS 12.5 X 12.5 CM; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800675

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Skin Discoloration (2074)

Event Date 03/30/2020

Event Type  Injury  

Event Description

It was reported that during the treatment for pressure ulcers utilizing hydrosite ad plus, it was confirmed the intact skin around the wound, which was under the dressing, discolored to brown.Stop using hydrosite ad plus and rinderon-v, betamethasone valerate was applied to the skin, and then the discoloration disappeared.No information about delay in treatment.The lot number of the product is unknown and the sample will not be returned due to the contamination./ skin discoloration.

Manufacturer Narrative

H3, h6: the device used in treatment has not been returned for evaluation, but photos and other additional information has been provided to establish a relationship between the device and the reported event.The photo supplied confirms discoloration of the skin.Probable cause or factors that can contribute to the reported events include, application, removal, time left on patient, materials used within the dressing, storage temperature, and or product failure.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.Medical review concluded information provided is insufficient to determine whether the patient¿s symptoms are due to a pre-existing or concurrent medical condition.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional risk management review is not required.No batch/lot number has been provided, therefore a review of the device history has not been possible.The complaint history file contains no further instances.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.

• Brand Name: HYDROSITE AD PLUS 12.5 X 12.5 CM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10158728
• MDR Text Key: 195275665
• Report Number: 8043484-2020-00755
• Device Sequence Number: 1
• Product Code: NAD
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800675
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 35