MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 SYSTEM FORCEP REFILL; INSTRUMENTS, DENTAL HAND

Catalog Number 659810V

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a pair of palodent v3 forceps broke during use; no injury resulted.

Manufacturer Narrative

Evaluation confirmed the device is broken as indicated in the complaint.Root causes not identified.Correction: a correction was made to the patient code.

Manufacturer Narrative

Evaluation confirmed the device is broken as indicated in the complaint.Root causes not identified.Correction: a correction was made to the patient code in h6.

• Brand Name: PALODENT V3 SYSTEM FORCEP REFILL
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• MDR Report Key: 8372562
• MDR Text Key: 140174039
• Report Number: 2515379-2019-00003
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 659810V
• Device Lot Number: A0315
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/23/2019
• Patient Sequence Number: 1