MAUDE Adverse Event Report: HU-FRIEDY MFG CO., LLC HU-FRIEDY EXCAVATOR (SUSPECTED)

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/10/2015

Event Type  Injury  

Manufacturer Narrative

Instrument not returned for evaluation.Unable to verify instrument catalog number and manufacturing date.Device not returned.

Event Description

On (b)(6), during a dental procedure, the instrument tip broke and was swallowed by patient.A local anesthetic was being used at the time of the procedure.Patient was sent to the er for x-rays and scoping procedure.X-rays showed tip went into the stomach but was unable to be found during scoping procedure.On (b)(6), another x-ray was taken and showed tip had moved down into the large intestine.On (b)(6), the tip had been removed via endoscopic procedure.On (b)(6), doctor reported he saw patient again for another tooth and patient will also be getting an mri due to pain in his lower gut area where tip was previously lodged.

• Brand Name: HU-FRIEDY EXCAVATOR (SUSPECTED)
• Type of Device: EXCAVATOR
• Manufacturer (Section D): HU-FRIEDY MFG CO., LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer Contact: maria vrabie ; 3232 n rockwell st; chicago, IL 60618 ; 7738685676
• MDR Report Key: 5051684
• MDR Text Key: 24876389
• Report Number: 1416605-2015-00004
• Device Sequence Number: 1
• Product Code: EKC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Dentist
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR