WECK CURRETTE TIP 20300 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 1998-08-12 for WECK CURRETTE TIP 20300 * manufactured by Pilling Weck Surgical.

Event Text Entries

[15028084] Medical record reviewed 4/14/98. Fourteen year old admitted for cholesteatoma to right ear and underwent right tympanomastoidectomy. During procedure ent currette tip broke. Two portions of the 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: 2515651-1998-00001
• MDR Report Key: 182573
• Report Source: 06,08
• Date Received: 1998-08-12
• Date of Report: 1998-08-12
• Date of Event: 1998-04-06
• Date Mfgr Received: 1998-05-13
• Date Added to Maude: 1998-08-18
• 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: 3
• Initial Report to FDA: 3
• 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: WECK CURRETTE TIP
• Generic Name: ENT CURRETTE
• Product Code: JYG
• Date Received: 1998-08-12
• Model Number: 20300
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 177501
• Manufacturer: PILLING WECK SURGICAL
• Manufacturer Address: 420 DELAWARE DR. FORT WASHINGTON PA 19034 US
• Baseline Brand Name: WECK CURRETTE TIP
• Baseline Generic Name: ENT CURRETTE
• Baseline Model No: 20300
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-08-12