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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-30 for * manufactured by Welch-allyn, Inc..

Event Text Entries

[770015] Anterior blade of a vaginal speculum cracked during opening, causing a linear mucosal tear in the anterior vaginal wall of the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 964878
• MDR Report Key: 964878
• Date Received: 2007-11-30
• Date of Report: 2007-11-30
• Date of Event: 2007-11-19
• Report Date: 2007-11-30
• Date Reported to FDA: 2007-11-30
• Date Added to Maude: 2007-12-17
• 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: *
• Generic Name: VAGINAL SPECULUM
• Product Code: HDF
• Date Received: 2007-11-30
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 934505
• Manufacturer: WELCH-ALLYN, INC.
• Manufacturer Address: 4341 STATE STREET ROAD SKANEATELES FALLS NY 13153 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-11-30