MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SKIN-PREP WIPES; BANDAGE, LIQUID, SKIN PROTECTANT

Model Number 420400

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Mother reports site is not adhering to skin very well.They have been using skin prep wipes.Author advised the skin prep wipes are used to create a barrier between skin and adhesive to help prevent irritation.Suggested they try not using skin prep wipes.No other information available.Reported to (b)(6) by pt/caregiver.

• Brand Name: SKIN-PREP WIPES
• Type of Device: BANDAGE, LIQUID, SKIN PROTECTANT
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 11760666
• MDR Text Key: 248859532
• Report Number: MW5101125
• Device Sequence Number: 1
• Product Code: NEC
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 420400
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1