MAUDE Adverse Event Report: RANIR LLC FLOSSER KIDS - TROPICAL

Lot Number 301328203

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Reaction (2414)

Event Date 06/01/2015

Event Type  Injury  

Event Description

Retailer stated their consumer's daughter is allergic to avocado and peanuts.She did not have a reaction to the orange handled flosser but when she used the blue flosser, her daughter had an itchy tongue and throat, which is the same reaction she gets when she ingests peanuts.

Manufacturer Narrative

Device not available.

• Brand Name: FLOSSER KIDS - TROPICAL
• Type of Device: FLOSSER
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 4869705
• MDR Text Key: 6047996
• Report Number: 1825660-2015-00067
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/25/2015

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: Other
• Device Lot Number: 301328203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1