MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY MFG. CO., LLC; CURETTE

Model Number SBH5/6C8

Device Problem Insufficient Information (3190)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/30/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Hu-friedy does not track our devices (which are mostly low risk class 1 devices) by serial number or udi, only by a lot number, which is tied to the date of manufacture.The product involved in the event does not have an expiration date.The device is not implanted, therefore implant/explant dates are not applicable.

Event Description

The tip of the instrument broke off in the patient's mouth.

Manufacturer Narrative

Follow-up report: on (b)(6) 2016, the patient's mother called the (b)(6) to report that the patient had passed the tip.Updated fields: the patients age has been updated.The date of event has been updated.Patient's relevant history has been updated.The operator of the device has been updated.

• Brand Name: HU-FRIEDY MFG. CO., LLC
• Type of Device: CURETTE
• Manufacturer (Section D): HU-FRIEDY MFG. CO., LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): 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: 5992317
• MDR Text Key: 56096080
• Report Number: 1416605-2016-00007
• Device Sequence Number: 1
• Product Code: EMS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SBH5/6C8
• Device Catalogue Number: SBH5/6C8
• Device Lot Number: 0712
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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): Other
• Patient Age: 23 YR