MAUDE Adverse Event Report: DENTSPLY (N.Z.) LIMITED V3 RING UNIVERSAL; INSTRUMENTS, DENTAL HAND

Catalog Number 403344

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Therefore, because medical intervention was required to preclude a serious injury, this event is reportable per 21cfr 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

It was reported that a v3 triodent universal ring was swallowed by a patient during a dental procedure.The clinician did not use a rubber dam as recommended per the ifu.The patient was sent to a gi specialist who retrieved the ring with an endoscope.

• Brand Name: V3 RING UNIVERSAL
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY (N.Z.) LIMITED; 11 marshall road; katikati, 3129 ; NZ 3129
• Manufacturer (Section G): DENTSPLY (N.Z.) LIMITED; 11 marshall road; katikati, 3129 ; NZ 3129
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178457551
• MDR Report Key: 6472663
• MDR Text Key: 72128988
• Report Number: 3003959465-2017-00001
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 403344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention