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.

• 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: 11150342
• MDR Text Key: 226216629
• Report Number: 8043484-2021-00078
• 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: 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 Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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 Received: 07/01/2021
• 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