IVALON Q604233

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 2001-12-06 for IVALON Q604233 manufactured by M-pact.

Event Text Entries

[219015] Several cases of dlk (diffuse lamellar keratitis).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1928508-2001-00003
• MDR Report Key: 365526
• Report Source: 05,06,07
• Date Received: 2001-12-06
• Date of Report: 2001-11-05
• Date Mfgr Received: 2001-11-08
• Date Added to Maude: 2001-12-14
• 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
• Manufacturer Contact: AL BOEDEKER
• Manufacturer Street: 1040 OCL PARKWAY
• Manufacturer City: EUDORA KS 66025
• Manufacturer Country: US
• Manufacturer Postal: 66025
• Manufacturer Phone: 7855422920
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IVALON
• Generic Name: PVA SURGICAL SPEAR
• Product Code: HOZ
• Date Received: 2001-12-06
• Model Number: Q604233
• Catalog Number: Q604233
• Lot Number: NR
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 354647
• Manufacturer: M-PACT
• Manufacturer Address: 1040 OCL PARKWAY EUDORA KS 66025 US
• Baseline Brand Name: IVALON
• Baseline Generic Name: PVA SURGICAL SPEAR
• Baseline Model No: Q604233
• Baseline Catalog No: Q604233
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-12-06