MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN SECURA CLEANSERS; BANDAGE, LIQUID, SKIN PROTECTANT

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Device Handling Problem (3265)

Patient Problem Cough (4457)

Event Date 06/14/2022

Event Type  Injury  

Event Description

It was reported that, during treatment with an unknown secura cleanser, the patient drank some of the product and subsequently experienced coughing.The patient was confirmed to be alert and oriented and they were instructed to call poison control.It is unknown which additional health consequences this had on the patient and how the adverse event was treated.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation, meaning the reported event could not be confirmed.A review of manufacturing records was not performed for this event; no batch lot number has been provided.A review of previous complaints against secura cleanser products found one other instance of a patient ingesting some of the product, against the labelling advice and instructions for use.A review of the relevant risk files found that the risk of a patient or user ingesting the product has been adequately mitigated.All secura cleanser products have clear instruction that they are intended for external use only, and contain warnings that should the product be ingested, that the patient is to seek medical help or contact poison control immediately a review of previous escalations or corrective actions could not be performed as a specific product or lot number was not provided for this complaint.A medical review found that without any further information into the patients health status or current condition, no conclusions can be made in relation to the clinical outcome of the reported event in relation to the product used.This complaint relates to an off-label unintended use of the product, and does not constitute a manufacturing related issue.A probable cause remains undetermined as to why the user ingested some of the cleanser, however the instructions for use delineates this use of the product, with advice should this situation occur.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.H6: health effect - impact code and medical device problem code.

• Brand Name: UNKN SECURA CLEANSERS
• Type of Device: BANDAGE, LIQUID, SKIN PROTECTANT
• 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: 14911747
• MDR Text Key: 295234719
• Report Number: 8043484-2022-00178
• Device Sequence Number: 1
• Product Code: NEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male