V. MUELLER D6 * RH750

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-02 for V. MUELLER D6 * RH750 manufactured by Allegiance V. Mueller.

Event Text Entries

[73684] Freer broke off leaving the tip in the pt while attempting a reduction of zygomatic fracture. Endoscope were used to retrieve the instrument tip.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 135261
• MDR Report Key: 135261
• Date Received: 1997-12-02
• Date of Report: 1997-11-11
• Date of Event: 1997-11-07
• Date Facility Aware: 1997-11-07
• Report Date: 1997-11-11
• Date Reported to FDA: 1997-11-11
• Date Reported to Mfgr: 1997-11-11
• Date Added to Maude: 1997-12-03
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: V. MUELLER D6
• Generic Name: FREER
• Product Code: GEG
• Date Received: 1997-12-02
• Model Number: *
• Catalog Number: RH750
• Lot Number: D6
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 132153
• Manufacturer: ALLEGIANCE V. MUELLER
• Manufacturer Address: 1425 LAKE COOK RD. DEERFIELD IL 60015 US
• Baseline Brand Name: FREER SEPTUM ELEVATORS DOUBLE ENDED 7.5"
• Baseline Generic Name: SEPTUM ELEVATOR
• Baseline Model No: RH750
• Baseline Catalog No: RH750
• Baseline ID: NA
• Baseline Device Family: ELEVATOR
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: *
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-12-02