MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REMOVE 8OZ WIPES; REMOVE WIPES CTN 50

Catalog Number 59403125

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Local Reaction (2035)

Event Date 04/17/2015

Event Type  Injury  

Event Description

It was reported that a patient developed a mild skin reaction, blistering, after usage of remove prior to placing a covidien ecg sensor on the patient¿s skin.The reporter states that it is unknown the causal relationship with the remove product or the ecg sensor¿s adhesive.

Manufacturer Narrative

Manufacturer Narrative

• Brand Name: REMOVE 8OZ WIPES
• Type of Device: REMOVE WIPES CTN 50
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 4734889
• MDR Text Key: 5707823
• Report Number: 3006760724-2015-00043
• Device Sequence Number: 1
• Product Code: KOX
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 59403125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1