MAUDE Adverse Event Report: 3M HEALTH CARE COBAN SELF-ADHERENT WRAP; COBAN WRAP

Catalog Number	1583
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	04/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer from a dermatology clinic reported a 1583 coban self adherent wrap was used to secure a gauze dressing on a (b)(6) y/o male patient.Customer reported the patient experienced an allergic reaction (itching,redness, burning and rash) on his leg where the wrap touched his skin.The reaction was treated with a 15 day course of oral prednisone and was reportedly improving four days after medication was started.

• Brand Name: COBAN SELF-ADHERENT WRAP
• Common Device Name: COBAN WRAP
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 5640851
• Report Number: 2110898-2016-00057
• Device Sequence Number: 12113937
• Product Code: FQM
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2016
• Initial Report FDA Received Date: 05/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR