MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SECURA MOIST CLEANSER 8OZ CAN; DEGREASER, SKIN, SURGICAL

Catalog Number 59430979

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

Patient Problems Fungal Infection (2419); Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that the patient was using the product sporadically for about 1 year and then started to use it everyday.The patient developed red marks, skin stripping and was painful.During use of the product the patient developed a yeast infection, bacterial vaginosis and is currently under medication.

Manufacturer Narrative

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 the product was incorrectly applied.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found one further instance 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: SECURA MOIST CLEANSER 8OZ CAN
• Type of Device: DEGREASER, SKIN, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10557102
• MDR Text Key: 207735611
• Report Number: 8043484-2020-02902
• Device Sequence Number: 1
• Product Code: KOY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 59430979
• Device Lot Number: 58484
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention