MAUDE Adverse Event Report: RANIR LLC PLACKERS FLOSSER; FLOSS, DENTAL

Model Number UNKNOWN FLOSSER

Device Problem Entrapment of Device (1212)

Patient Problems Dyspnea (1816); Pain (1994); Foreign Body In Patient (2687)

Event Date 04/28/2021

Event Type  malfunction  

Event Description

Consumer stated: i swallowed the toothpick part of a placker 3 days ago, it broke off the floss handle.I haven't noticed if i have passed it yet or not.I contacted my doctor and was told it should pass, if i have a sharp pain or shortness of breath to go to the emergency room.My question is will the placker break down in my system or will it pass as it entered? what materials are used to make the placker? followed up with consumer and he stated: thank you for your response.Great news, it passed!.

• Brand Name: PLACKERS FLOSSER
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: rebekah hamilton ; 6166988880
• MDR Report Key: 11896496
• MDR Text Key: 258685363
• Report Number: 1825660-2021-00961
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/27/2021

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 Model Number: UNKNOWN FLOSSER
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2021
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1