MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC N/A; HANDLE, INSTRUMENT, DENTAL

Catalog Number PFIWDS 1

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

During a dental procedure, part of the dental instrument broke off into the patient.After the scheduled procedure, the patient had to be taken to the operating room to remove the foreign body.Manufacturer response for woodson periosteal double ended dental instrument, (brand not provided) (per site reporter): the manufacturer opened up a complaint and requested the tool back for further investigation.

• Brand Name: N/A
• Type of Device: HANDLE, INSTRUMENT, DENTAL
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 north rockwell st.; chicago, IL 60618
• MDR Report Key: 5602982
• MDR Text Key: 43507980
• Report Number: 5602982
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Unknown
• Device Catalogue Number: PFIWDS 1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention