PROVENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-07 for PROVENT manufactured by Ventus Medical.

Event Text Entries

[19997585] Use of provent sleep apnea product - have used. I have recently started using your product. Since i started using provent (standard) over the past 12 days have noticed an extreme difference in easy of exhale through my nose to a greater resistance in exhaling. My concern is quality control - fact each night's use of a sealed provent pac over the past two weeks has come from the same 30 day package labeled with lot number # 31536 s07, with an expiration date of 2015-01 and labeled standard resistance sr. I believe we all know how important breathing is for us with sleep apnea. I have a 90 day supply of defective items mixed in with correctly produced items. Please provide me with guidance as how i should proceed in use with the remaining 2 and half months all from the same lot number. I have included the supplier on this email, and will also contact fda. Really don't know which of the products is providing me with the correct pressure while sleeping. Provent sleep therapy - standard resistance - single use only lot # 31536 s07, serial number (b)(4). Days of use (b)(6) 2013. One use only, daily, nasal.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5029692
• MDR Report Key: 3052768
• Date Received: 2013-04-07
• Date of Report: 2013-04-07
• Date of Event: 2013-03-28
• Date Added to Maude: 2013-04-12
• 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
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROVENT
• Generic Name: PROVENT SLEEP APNEA THERAPY
• Product Code: OHP
• Date Received: 2013-04-07
• ID Number: TYPE- STANDARD
• Device Expiration Date: 2015-01-31
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: VENTUS MEDICAL
• Manufacturer Address: 1301 SHOREWAY ROAD SUITE 425 BELMONT CA 94002 US 94002

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-04-07