MAUDE Adverse Event Report: COVIDIEN/MEDTRONIC WALGREENS; ANTIBACTERIAL GAUZE PADS 2X2

Model Number UPC311917151434

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Erosion (2075); Skin Irritation (2076)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

As of 05/02/2016, aso has not received returned samples from the retailer.Aso contacted the manufacturer on 04/07/2016 to inform about the complaint.Manufacturer is awaiting on returned samples.

Event Description

Consumer reported that sterile pads with phmb caused her an allergic reaction, her skin became raw and she sought medical attention.

Manufacturer Narrative

As of 05/02/16 aso has not received returned samples from the retailer.Aso contacted the manufacturer on 04/07/2016 to inform about the complaint.Manufacturer is awaiting on returned samples.As of 10/24/2016 aso sent unused returned sample to the manufacturer for further investigation.

Event Description

Consumer reported that sterile pads with phmb caused her an allergic reaction, her skin became raw and she sought medical attention.

• Brand Name: WALGREENS
• Type of Device: ANTIBACTERIAL GAUZE PADS 2X2
• Manufacturer (Section D): COVIDIEN/MEDTRONIC; 15 hampshire st.; mansfiled MA 30906
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: federico juliao ; 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 5624653
• MDR Text Key: 44293909
• Report Number: 1038758-2016-00064
• Device Sequence Number: 1
• Product Code: EFQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/01/2018
• Device Model Number: UPC311917151434
• Device Catalogue Number: 220544
• Device Lot Number: 37604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2015
• 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