MAUDE Adverse Event Report: AISCO INDUSTRIES, INC. GLIDE PRO-HEALTH DEEP CLEAN FLOSS ORAL-B

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/24/2017

Event Type  malfunction  

Event Description

Oral-b's mint-flavored dental flosses caused an allergic reaction on my lips and around my mouth.This is the case for more than one mint type of floss.

• Brand Name: GLIDE PRO-HEALTH DEEP CLEAN FLOSS ORAL-B
• Type of Device: FLOSS
• Manufacturer (Section D): AISCO INDUSTRIES, INC.
• MDR Report Key: 6995863
• MDR Text Key: 90955469
• Report Number: MW5073094
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 57