WECK CURRETTE TIP 20300 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-30 for WECK CURRETTE TIP 20300 * manufactured by Pilling Weck Surgical.

Event Text Entries

[18831418] Med record reviewed 4-14-98. Fourteen yr old admitted for cholesteatoma to right ear and underwent right tympanomastoidectomy. During procedure, ent currette tip broke. Two portions of tip recovered and x-rays performed to rule out retained foreign body.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1013677
• MDR Report Key: 165465
• Date Received: 1998-04-30
• Date of Report: 1998-04-14
• Date of Event: 1998-04-06
• Date Added to Maude: 1998-05-05
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WECK CURRETTE TIP
• Generic Name: ENT CURRETTE TIP
• Product Code: JYG
• Date Received: 1998-04-30
• Model Number: 20300
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 161045
• Manufacturer: PILLING WECK SURGICAL
• Manufacturer Address: 420 DELAWARE DR. FT. WASHINGTON PA 19034 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-04-30