MAUDE Adverse Event Report: RANIR LLC DENTAL FLOSS

Lot Number 3331

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

Patient Problem Reaction (2414)

Event Date 07/03/2014

Event Type  Injury  

Event Description

We bought two packets of tooth floss picks mint flavor and when we used them we noticed they all have a cheese taste to them; all of them.They ended up giving both adults bad toothaches my boyfriend stopped using them and switched to regular floss and his toothache went away i however kept using them and now have to go to the dentist because my tooth is in so much pain.I brought the tooth picks and they stated the waxing on it has something different that caused this issue.

Manufacturer Narrative

Consumer and her boyfriend had what appeared to be a potential allergic reaction.The complaint is not confirmed that it was caused by the flosser.Because consumer states they had a reaction after her and her boyfriend used the flosser, it is considered to be a serious injury, event if only temporary in nature, and is a reportable event.Consumer (s) did not seek med attention, and any known allergies by consumer(s) 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 regard ing 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: 3987042
• MDR Text Key: 15108464
• Report Number: 1825660-2014-00885
• 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: 07/16/2014

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: 3331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/03/2014
• 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