MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 FORCEPS; INSTRUMENTS, DENTAL HAND

Catalog Number 659810V

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it is reported palodent v3 forceps broke during use.Broken pieces were all retrieved from patient's mouth.No additional treatment necessary.No injury occurred.

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.A dhr review was conducted with no discrepancies noted.

• Brand Name: PALODENT V3 FORCEPS
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 14850281
• MDR Text Key: 303264393
• Report Number: 2515379-2022-00047
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 659810V
• Device Lot Number: 05238297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/27/2022
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1