CONMED BEND-A-BEAM ABC HANDPIECE 134006

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1997-03-19 for CONMED BEND-A-BEAM ABC HANDPIECE 134006 manufactured by Conmed Corp..

MAUDE Entry Details

• Report Number: 1317214-1997-00029
• MDR Report Key: 78307
• Report Source: 05,06,07
• Date Received: 1997-03-19
• Date of Report: 1997-02-20
• Date of Event: 1997-02-20
• Date Mfgr Received: 1997-02-20
• Device Manufacturer Date: 1996-09-01
• Date Added to Maude: 1997-03-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CONMED BEND-A-BEAM ABC HANDPIECE
• Generic Name: ABC HANDPIECE
• Product Code: HQP
• Date Received: 1997-03-19
• Model Number: NA
• Catalog Number: 134006
• Lot Number: J86373A
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 77931
• Manufacturer: CONMED CORP.
• Manufacturer Address: 1435-J HENRY BREENAN DR. EL PASO TX 79936 US
• Baseline Brand Name: CONMED BEND-A-BEAM ABC HANDPIECE
• Baseline Generic Name: ABC HANDPIECE
• Baseline Model No: NA
• Baseline Catalog No: 134006
• Baseline ID: NA
• Baseline Device Family: ABC UNITS AND ACCESSORIES
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K961505
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-03-19