ALLERGAN CUP (GORETEX) NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2000-01-28 for ALLERGAN CUP (GORETEX) NI manufactured by Allergan.

Event Text Entries

[19235651] The mfr of a contact lens care cup for use with 3% hydrogen peroxide systems received a report from foreign country that a cup burst during use. No injury occurred. The mfr is investigating.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2011068-1999-00016
• MDR Report Key: 260602
• Report Source: 01,04
• Date Received: 2000-01-28
• Date of Report: 1999-10-04
• Date Mfgr Received: 1999-10-04
• Date Added to Maude: 2000-02-03
• 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 Contact: DAVE GARBE
• Manufacturer Street: 2525 DUPONT DRIVE P.O. BOX 19534
• Manufacturer City: IRVINE CA 926239534
• Manufacturer Country: US
• Manufacturer Postal: 926239534
• Manufacturer Phone: 7142464285
• 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: ALLERGAN CUP (GORETEX)
• Generic Name: CONTACT LENS CARE PRODUCT
• Product Code: HRD
• Date Received: 2000-01-28
• Returned To Mfg: 1999-11-10
• Model Number: NI
• Catalog Number: NI
• Lot Number: UNK
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: I
• Device Sequence No: 1
• Device Event Key: 252409
• Manufacturer: ALLERGAN
• Manufacturer Address: 2525 DUPONT DR. P.O. BOX 19534 IRVINE CA 926239534 US

Patients

Patient Number	Treatment	Outcome	Date
1	2		2000-01-28