MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 3.5 EZ COAT REFLL; INSTRUMENTS, DENTAL HAND

Catalog Number 659610V

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, 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 is reported that a patient may have experienced an adverse reaction after undergoing a dental procedure that involved the use of palodent v3.It is reported that patient presented with redness of buccal gingiva and has an allergy to nickel.Outcome of this event is unknown as of this mdr.

Manufacturer Narrative

Product will not be returned, it is not a complaint.Lot number unknown, unable to do a retain investigation.

• Brand Name: PALODENT V3 3.5 EZ COAT REFLL
• 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: 15880726
• MDR Text Key: 304503132
• Report Number: 2515379-2022-00057
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 659610V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/22/2022
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1