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

Catalog Number UNKNOWN

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

Patient Problem Discomfort (2330)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient called in requesting a new "device" because she inadvertently sprayed antimicrobial cleanser, secura, into her face while she was talking to someone.She stated few drops had gotten into her eyes and that she may have also swallowed a little bit of the cleanser.She is worried about " if she poison herself." so she took the time to rinse out her mouth and chewed candies hoping that the chemicals would stick into the candy and she spit it out.But now she reported she has a funny taste in her mouth.Patient was instructed to let her nurse know immediately as she is a resident of a skilled nursing facility.No additional information is available.

Manufacturer Narrative

H3, h6: the device that was used in treatment was not returned for evaluation, with all information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause may include improper use.No lot/serial number has been provided; therefore, a review is not possible.A complaint history review found no further instances of the reported event.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.Instructions for use contains recommendations and precautionary statements for proper use of product.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• 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
• MDR Report Key: 11150342
• MDR Text Key: 226216629
• Report Number: 8043484-2021-00078
• Device Sequence Number: 1
• Product Code: NEC
• 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: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• 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
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention