MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 NARROW 2 RING REFL; INSTRUMENTS, DENTAL HAND

Catalog Number 659770V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

While there has been no information received that the patient was injured, ingestion can lead to a possibility of surgical intervention to remove the swallowed piece.Therefore, this event is reportable 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.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Event Description

In this event it is reported that palodent v3 narrow 2 ring refl was ingested by a patient.The practice reports that the patient is fine.The patient will be referred for an x-ray.The outcome of this event is unknown as of this mdr.Further information requested.

• Brand Name: PALODENT V3 NARROW 2 RING REFL
• 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: 19043183
• MDR Text Key: 339463447
• Report Number: 2515379-2024-00016
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D002659770V1
• UDI-Public: D002659770V1
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 04/04/2024

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 Catalogue Number: 659770V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/04/2024
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/04/2024
• Type of Device Usage: A
• Patient Sequence Number: 1