HUDSON BITE-GARD MOLAR BITE BLOCK 1140

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2014-03-12 for HUDSON BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.

Event Text Entries

[4573955] The event is reported as: the customer alleges that the bite-gard broke while in use. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5

[12156590] The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3004365956-2014-00107
• MDR Report Key: 3938106
• Report Source: 01,06,08
• Date Received: 2014-03-12
• Date of Report: 2014-02-13
• Date of Event: 2014-01-27
• Date Mfgr Received: 2014-02-13
• Date Added to Maude: 2014-07-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MARGIE BURTON, RN
• Manufacturer Street: PO BOX 12600
• Manufacturer City: DURHAM NC 27709
• Manufacturer Country: US
• Manufacturer Postal: 27709
• Manufacturer Phone: 9194334965
• Manufacturer Street: AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HUDSON BITE-GARD MOLAR BITE BLOCK
• Generic Name: BITE BLOCK
• Product Code: JXL
• Date Received: 2014-03-12
• Returned To Mfg: 2014-02-25
• Catalog Number: 1140
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TELEFLEX MEDICAL
• Manufacturer Address: NUEVO LAREDO, TAMAULIPAS MX

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-03-12