KAHN UTERINE CANNULA GL2360

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-05-20 for KAHN UTERINE CANNULA GL2360 manufactured by Allegiance Healthcare Corp..

Event Text Entries

[131524] The white silicone tip is breaking off and falling into the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1423507-1999-00136
• MDR Report Key: 224104
• Report Source: 05,06
• Date Received: 1999-05-20
• Date of Report: 1999-05-20
• Date Mfgr Received: 1999-04-21
• Device Manufacturer Date: 1998-01-01
• Date Added to Maude: 1999-05-24
• 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: KAHN UTERINE CANNULA
• Generic Name: INSTRUMENT
• Product Code: HGH
• Date Received: 1999-05-20
• Returned To Mfg: 1999-04-29
• Model Number: GL2360
• Catalog Number: GL2360
• Lot Number: ZJ
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 217313
• Manufacturer: ALLEGIANCE HEALTHCARE CORP.
• Manufacturer Address: 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US
• Baseline Brand Name: KAHN UTERINE CANNULA
• Baseline Generic Name: INSTRUMENT
• Baseline Model No: GL2360
• Baseline Catalog No: GL2360
• Baseline ID: NA
• Baseline Device Family: INSTRUMENT
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-05-20