FLEXIFIT SERIES HC407 NASAL MASK HC407A *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-02-27 for FLEXIFIT SERIES HC407 NASAL MASK HC407A * manufactured by Fisher & Paykel Healthcare.

Event Text Entries

[586088] Pt experienced possible allergic reaction.
Patient Sequence No: 1, Text Type: D, B5

[7925841] Awaiting further info.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 9611451-2007-00049
• MDR Report Key: 822537
• Report Source: 08
• Date Received: 2007-02-27
• Date of Report: 2007-02-27
• Date of Event: 2006-11-14
• Date Mfgr Received: 2006-12-17
• Date Added to Maude: 2007-03-05
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: JULIE COFORTH
• Manufacturer Street: 15 MAURICE PAYKEL PLACE EAST TAMAKI
• Manufacturer City: PANMURE, AUCKLAND 1741
• Manufacturer Country: NZ
• Manufacturer Postal: 1741
• Manufacturer Phone: 5740100
• 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: FLEXIFIT SERIES HC407 NASAL MASK
• Generic Name: NASAL CPAP MASK
• Product Code: NMC
• Date Received: 2007-02-27
• Model Number: HC407A
• Catalog Number: *
• Lot Number: UNK
• ID Number: *
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 809941
• Manufacturer: FISHER & PAYKEL HEALTHCARE
• Manufacturer Address: * AUCKLAND NZ
• Baseline Brand Name: FLEXIFIT SERIES HC407 NASAL MASK
• Baseline Generic Name: NASAL CPAP MASK
• Baseline Model No: HC407A
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-02-27