AUFRICHT RETRACTOR-SPECULUM RH1280

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-07-22 for AUFRICHT RETRACTOR-SPECULUM RH1280 manufactured by Allegiance Healthcare Corp..

Event Text Entries

[140648] Aufricht retractor being used to hold nose nostril. Tip of instrument broke off causing a 4cm scratch to pt's left cheek, sutures required.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1423507-1999-00213
• MDR Report Key: 233171
• Report Source: 05,06
• Date Received: 1999-07-22
• Date of Report: 1999-07-21
• Date of Event: 1999-06-09
• Date Mfgr Received: 1999-07-12
• Date Added to Maude: 1999-07-28
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AUFRICHT RETRACTOR-SPECULUM
• Generic Name: INSTRUMENT
• Product Code: KAL
• Date Received: 1999-07-22
• Model Number: RH1280
• Catalog Number: RH1280
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 226006
• Manufacturer: ALLEGIANCE HEALTHCARE CORP.
• Manufacturer Address: 1500 WAUKEGAN RD MCGAW PARK IL 60085 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		1999-07-22