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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW MEDICAL LTD. SKIN-PREP WIPES BOX 50 01 BANDAGE, LIQUID, SKIN PROTECTANT Back to Search Results
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.
 
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Brand NameSKIN-PREP WIPES BOX 50 01
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
MDR Report Key12057889
MDR Text Key258061567
Report Number8043484-2021-01558
Device Sequence Number1
Product Code NEC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number420400
Device Lot Number12470
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 Received09/20/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/28/2020
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
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