MAUDE Adverse Event Report: RANIR LLC SHOPPERS DRUG MART; FLOSS, DENTAL

Model Number FLSP MNT 90

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 09/07/2016

Event Type  No Answer Provided  

Manufacturer Narrative

With no sample all conclusions will only be speculation.With that said the end-user¿s dental condition was likely a significant factor in the event.

Event Description

(b)(6) used this item and when she used it on her back molar, she says it chipped off a piece of the tooth.She wants sdm to pay for her tooth repair.

• Brand Name: SHOPPERS DRUG MART
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512
• Manufacturer Contact: brenda mumbower ; 4701 east paris ave se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 6000837
• MDR Text Key: 56497821
• Report Number: 1825660-2016-00020
• 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
• Reporter Occupation: Device Unattended
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: FLSP MNT 90
• Device Lot Number: 46655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/07/2016
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1