WOLF 8294.13 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-30 for WOLF 8294.13 * manufactured by Richard Wolf.

Event Text Entries

[65715] At completion of right pleuroscopy when sprayer was removed from trocar, the rubber tip fell off in the chest cavity.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 103736
• MDR Report Key: 103736
• Date Received: 1997-06-30
• Date of Report: 1997-06-09
• Date of Event: 1997-06-05
• Date Facility Aware: 1997-06-05
• Report Date: 1997-06-09
• Date Added to Maude: 1997-07-10
• 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: WOLF
• Generic Name: SPRAYER
• Product Code: KCL
• Date Received: 1997-06-30
• Model Number: 8294.13
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 102062
• Manufacturer: RICHARD WOLF
• Manufacturer Address: 353 CORPORATE WOODS PARKWAY VERNON HILLS IL 60061 US
• Baseline Brand Name: PLEURADESIS DUSTING TUBE
• Baseline Generic Name: DUSTING TUBE
• Baseline Model No: 8294.13
• Baseline Catalog No: 8294.13
• Baseline ID: A-G-U
• Baseline Device Family: PLEURADESIS DUSTING TUBE
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1997-06-30