MAUDE Adverse Event Report: RANIR LLC DENTAL FLOSS

Lot Number 073907

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

Patient Problem Reaction (2414)

Event Date 06/27/2014

Event Type  Injury  

Event Description

What are the ingredients in this item? does it contain artificial flavors? i really need to know because i'm sensitive to that.I used it once and now i am having a reaction.

Manufacturer Narrative

Consumer had what appeared to be a potential allergic reaction.The complaint is not confirmed that it was caused by the floss.Because consumer states after using the floss one time, she had a reaction possibly due to her insensitivity to artificial flavors, it is considered to be a serious injury, even if only temporary in nature, and is a reportable event.Consumer did not seek med attention, and any known allergies by consumer have not been confirmed.The dental floss was not returned to the mfr, so we cannot perform a full investigation.We would need additional info regarding the event to complete a full investigation.

• Brand Name: DENTAL FLOSS
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. s.e.; grand rapids MI 49512
• Manufacturer Contact: 4701 east paris ave. s.e.; grand rapids, MI 49512
• MDR Report Key: 3987046
• MDR Text Key: 4820749
• Report Number: 1825660-2014-00874
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/02/2014

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: Lay User/Patient
• Device Lot Number: 073907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2014
• Initial Date FDA Received: 07/24/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening