* 705101 N/S 405101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-21 for * 705101 N/S 405101 manufactured by Medtronic Xomed Corporation.

Event Text Entries

[502454] Rptr has sent in product for testing with no real answers or admission there is a current problem. During this time, rptr learned that in the past, there were similar problems that mfr was aware of and moved the product form a generally excepted method of packaging to a foil pack per our conversation. The steps we took were to remove the product from inside the pack and piggyback the product to the outside of the packs. This action has been implemented and we are now cycling thru the finished goods with the spears in the pack. The unused product is being boxed to return to mfr. We now have an additional complaint that was reported to rptr 6/06. There are two surgeons that reported seeing fibers on the eye, under microscopic examination during their procedure. The fibers are reported to come from mfr's eye spears. It is not necessary for me to explain the severity of this product complaint. These fibers came from the fresh product that mfr recently shipped rptr that was given to the customer at no charge.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4004215
• MDR Report Key: 757703
• Date Received: 2006-06-21
• Date Added to Maude: 2006-09-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• 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: *
• Generic Name: *
• Product Code: HNL
• Date Received: 2006-06-21
• Model Number: *
• Catalog Number: 705101 N/S 405101
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 745601
• Manufacturer: MEDTRONIC XOMED CORPORATION
• Manufacturer Address: 6743 SOUTH POINT DRIVE NORTH JACKSONVILLE FL 32216 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-06-21