*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-22 for * manufactured by V. Mueller Opex.

Event Text Entries

[19074822] Aufricht retractor being used to hold nose nostril. Tip of instrument broke off causing a 4 cm scratch to pt's left cheek. Sutures required.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 233166
• MDR Report Key: 233166
• Date Received: 1999-07-22
• Date of Report: 1999-06-18
• Date of Event: 1999-06-09
• Date Facility Aware: 1999-06-09
• Report Date: 1999-06-18
• Date Reported to Mfgr: 1999-06-18
• Date Added to Maude: 1999-07-28
• 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
• 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: *
• Generic Name: AUFRICHT RETRACTOR
• Product Code: KAL
• Date Received: 1999-07-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 226006
• Manufacturer: V. MUELLER OPEX
• Manufacturer Address: 4300 NINE MILE RD. NOVA MI 48375 US
• Baseline Brand Name: AUFRICHT RETRACTOR-SPECULUM
• Baseline Generic Name: INSTUMENT
• Baseline Model No: RH1280
• Baseline Catalog No: RH1280
• Baseline ID: NA
• Baseline Device Family: INSTRUMENT
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-07-22