SUPERTRAX AK100101-01 21 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-14 for SUPERTRAX AK100101-01 21 * manufactured by Superdimenson, Ltd..

MAUDE Entry Details

• Report Number: 3033441
• MDR Report Key: 3033441
• Date Received: 2013-02-14
• Date of Report: 2013-02-14
• Date of Event: 2013-01-08
• Report Date: 2013-02-14
• Date Reported to FDA: 2013-02-14
• Date Reported to Mfgr: 2013-04-03
• Date Added to Maude: 2013-04-03
• 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: 3
• 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 Sequence Number: 1

• Brand Name: SUPERTRAX
• Generic Name: BIOPSY
• Product Code: GAA
• Date Received: 2013-02-14
• Model Number: AK100101-01 21
• Catalog Number: *
• Lot Number: SD06-12-215
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SUPERDIMENSON, LTD.
• Manufacturer Address: 161 CHESHIRE LANE, SUITE 100 MINNEAPOLIS MN 55441543 US 55441 5433

Device Sequence Number: 2

• Brand Name: SUPERTRAX
• Generic Name: BIOPSY
• Product Code: DWO
• Date Received: 2013-02-14
• Model Number: AK100101-01 21
• Catalog Number: *
• Lot Number: 15356
• ID Number: *
• Device Availability: N
• Device Age: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SUPERDIMENSON, LTD.
• Manufacturer Address: 161 CHESHIRE LANE, SUITE 100 MINNEAPOLIS MN 55441543 US 55441 5433

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-02-14