MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC DUAL CHAMBER SYRINGE SEALER; RIBBON

Catalog Number RIBBON

Device Problem Overfill (2404)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

While there is no indication that the ribbon used malfunctioned, because this event may result in permanent damage to a body function/structure, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

In this event it was reported that ribbon sealer extruded past a patient's apex, and the patient was feeling pain.

• Brand Name: DUAL CHAMBER SYRINGE SEALER
• Type of Device: RIBBON
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• MDR Report Key: 12671855
• MDR Text Key: 277624152
• Report Number: 2320721-2021-00083
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• PMA/PMN Number: K960548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/20/2021

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: No Information
• Device Catalogue Number: RIBBON
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1