MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SKIN-PREP WIPES BOX 50 01 BANDAGE, LIQUID, SKIN PROTECTANT

Catalog Number 420400

Device Problems Nonstandard Device (1420); Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Local Reaction (2035); Skin Tears (2516)

Event Date 06/03/2021

Event Type  Injury  

Event Description

It was reported that, after insulin pump therapy, the patient started experiencing redness and skin stripping about a couple of months ago. Patient uses skin-prep wipes to prepare for cannulation site and iv3000 1 hand 6x7cm to fixate the catheter and protect insertion site, so this adverse event could have been caused by either. Patient, who has been using our products for about 20 years, also claims that quality of such products has decreased recently, so they are not fulfilling their function to protect skin as they should. It is unknown how the patient has been alleviating/treating the injured skin.

• Brand Name: SKIN-PREP WIPES BOX 50 01
• 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
• MDR Report Key: 12057889
• MDR Text Key: 258061567
• Report Number: 8043484-2021-01558
• Device Sequence Number: 1
• Product Code: NEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 420400
• Device Lot Number: 12470
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2020
• 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: 06/24/2021 Patient Sequence Number: 1