MAUDE Adverse Event Report: DENTSPLY CAULK PALODENT PLUS FORCEPS; DENTAL HAND INSTRUMENT

Catalog Number 659810

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

In this event it was reported that a pair of palodent plus forceps at the tip; no injury resulted.

Manufacturer Narrative

While no serious injury resulted in this event, there has been a previous report received in the past two years 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 eval, though results are not available as of this report.Eval results will be submitted as they become available.

• Brand Name: PALODENT PLUS FORCEPS
• Type of Device: DENTAL HAND INSTRUMENT
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st, ste 60; susquehanna commerce ctr w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4214917
• MDR Text Key: 5001422
• Report Number: 2515379-2014-00065
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/08/2014

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 Operator: Health Professional
• Device Catalogue Number: 659810
• Device Lot Number: D0113
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1