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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW MEDICAL LTD. UNKN SECURA CLEANSERS BANDAGE, LIQUID, SKIN PROTECTANT Back to Search Results
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.
 
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Brand NameUNKN SECURA CLEANSERS
Type of DeviceBANDAGE, 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 Key11150342
MDR Text Key226216629
Report Number8043484-2021-00078
Device Sequence Number1
Product Code NEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
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 Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
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 Treatment Data
Date Received: 01/11/2021 Patient Sequence Number: 1
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