REDI-READERS - ANIMAL PRINT * NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2001-08-14 for REDI-READERS - ANIMAL PRINT * NA manufactured by Ni.

Event Text Entries

[208933] Customer poked self in the eye with the label called a hang tag.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1045828-2001-00001
• MDR Report Key: 347917
• Report Source: 00,04
• Date Received: 2001-08-14
• Date of Report: 2001-08-13
• Date of Event: 2000-12-29
• Date Facility Aware: 2001-08-08
• Report Date: 2001-08-13
• Date Reported to Mfgr: 2001-08-08
• Date Mfgr Received: 2001-08-08
• Date Added to Maude: 2001-08-22
• 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: 3
• Manufacturer Street: 3700 COMMERCE PARKWAY
• Manufacturer City: MIRAMAR FL 33025
• Manufacturer Country: US
• Manufacturer Postal: 33025
• Manufacturer Phone: 9549869000
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: REDI-READERS - ANIMAL PRINT
• Generic Name: READING GLASSES #5426 +1.50
• Product Code: HOI
• Date Received: 2001-08-14
• Model Number: *
• Catalog Number: NA
• Lot Number: NA
• ID Number: UPC: 718154062262
• Operator: OTHER
• Device Availability: N
• Device Age: NO INFO
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 337239
• Manufacturer: NI
• Manufacturer Address: NI NI * NI
• Baseline Brand Name: REDI-READERS - ANIMAL PRINT
• Baseline Generic Name: READING GLASSES #5426 +1.50
• Baseline Model No: *
• Baseline Catalog No: NA
• Baseline ID: UPC: 7181540622

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-08-14