MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. HYDROSITE USUGATA 10 X 10CM CTN 5; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66390873

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that the hydrosite usugata 10 x 10cm ctn 5 had foreign substance.The treatment was completed, without delay, using a s+n back up device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

It was reported that the hydrosite usugata 10 x 10cm ctn 5 had foreign substance.The treatment was completed, without delay, using a s+n back up device.Patient was not harmed as consequence of this problem.The device was used for treatment and was returned for analysis.The sample had an unknown contaminant embedded within the foam layer.We have been able to confirm a relationship between the event and the device.The batch records were reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review revealed no similar instances in the last three years.A risk management review concluded that without further information the alleged failure mode and any associated harm can not be directly linked to a specific failure mode within the risk file although it does contain several failure modes that can result in contamination.No updates to the risk files is required.The root cause was contamination in the foam layer of the device, which was supplied by an external supplier.This has therefore been escalated to the supplier to carry out further investigation into the cause of the contamination.This investigation is now complete, with escalation actions in place.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: HYDROSITE USUGATA 10 X 10CM CTN 5
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13478490
• MDR Text Key: 285958506
• Report Number: 8043484-2022-00052
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66390873
• Device Lot Number: 2116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1