INDIANA TOME 200060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-02-15 for INDIANA TOME 200060 manufactured by Biomet, Inc..

Event Text Entries

[19891302] Carpal tunnel release performed on 05/28/97. Pt underwent second surgical procedure to repair lacerated commin digital nerves.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1825034-1999-00018
• MDR Report Key: 210273
• Report Source: 00
• Date Received: 1999-02-15
• Date of Report: 1999-02-12
• Date of Event: 1998-02-27
• Date Mfgr Received: 1999-01-13
• Date Added to Maude: 1999-02-19
• 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
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INDIANA TOME
• Generic Name: INSTRUMENT, MANUAL, SURGICA
• Product Code: EKD
• Date Received: 1999-02-15
• Model Number: NA
• Catalog Number: 200060
• Lot Number: UNK
• 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: 204069
• Manufacturer: BIOMET, INC.
• Manufacturer Address: PO BOX 587 WARSAW IN 465810587 US
• Baseline Brand Name: INDIANA TOME
• Baseline Generic Name: INSTRUMENT, MANUAL, SURGICA
• Baseline Model No: NA
• Baseline Catalog No: 200060
• Baseline ID: NA
• Baseline Device Family: INDIANA TOME
• 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. Required No Informationntervention	1999-02-15