*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-23 for * manufactured by Unk.

Event Text Entries

[330206] A glass tonsil syringe broke while injecting but appeared intact. A glass piece was retrieved from the surgical drape but none was found on the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 490848
• MDR Report Key: 490848
• Date Received: 2003-10-23
• Date of Report: 2003-04-01
• Date of Event: 2003-02-01
• Date Added to Maude: 2003-10-24
• 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: TONSIL SYRINGE
• Product Code: KBZ
• Date Received: 2003-10-23
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 479575
• Manufacturer: UNK
• Manufacturer Address: UNK UNK * UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-10-23