*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for * manufactured by Unk.

Event Text Entries

[54589] While attempting to insert chest tube, hemostat broke and piece had to be removed under fluoroscopy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 91619
• MDR Report Key: 91619
• Date Received: 1994-07-21
• Date of Event: 1994-04-19
• Date Added to Maude: 1997-05-20
• 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
• 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: HEMOSTAT
• Product Code: HRQ
• Date Received: 1994-07-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 90506
• Manufacturer: UNK
• Manufacturer Address: UNK UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1994-07-21