MAUDE Adverse Event Report: ASO LLC WALGREENS; FABRIC ANTIBACTERIAL XL BANDAGE

Model Number UPC311917143347

Device Problem Failure to Obtain Sample (2533)

Patient Problem Abrasion (1689)

Event Date 01/29/2016

Event Type  Injury  

Manufacturer Narrative

As of 03/18/2016 aso has not received response from consumer regarding request for information on device or returned samples of the same.Aso has reviewed records of biocompatibility test data.Aso will follow-up with the consumer according to our procedures and follow-up on this report if there is any new information.

Event Description

Consumer reported that during removal of bandage, the bandage ripped her skin on her upper left leg which left the area raw.

• Brand Name: WALGREENS
• Type of Device: FABRIC ANTIBACTERIAL XL BANDAGE
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• 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: 5511190
• MDR Text Key: 40699050
• Report Number: 1038758-2016-00041
• Device Sequence Number: 1
• Product Code: KGX
• 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
• Report Date: 02/17/2016

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
• Device Operator: No Information
• Device Model Number: UPC311917143347
• Device Catalogue Number: 156743
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1