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

Catalog Number 1583

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Local Reaction (2035)

Event Date 04/25/2016

Event Type  Injury  

Event 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
• Type of Device: COBAN WRAP
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: karen krenik, bsn ; 3m center building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517333091
• MDR Report Key: 5640851
• MDR Text Key: 44725296
• Report Number: 2110898-2016-00057
• Device Sequence Number: 1
• Product Code: FQM
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR