PROVENT SLEEP APNEA THERAPY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for PROVENT SLEEP APNEA THERAPY manufactured by Provent Sleep Therapy.

Event Text Entries

[61023957] Provent was defective. The mesh came unglued from the backing on both nostrils during the night, so the device did not work. All resistance to breathing was lost, leading to apneic episodes and fatigue the following day. This has happened a few times in recent weeks. Another problem is that the product doesn't stick well to the skin, even after thoroughly washing the skin and removing all oil with an alcohol wipe. I now put paper tape around all of the edges so it sticks to my skin, and then it works very well (except when it malfunctions, as described above). The company should either make the product stick better to the patient's skin or recommend that paper tape be used to make it stick better. Because sleep apnea greatly increases morbidity and mortality, i would anticipate that this would save a lot of lives. Having said this, it's a great product for the millions of people who can't use cpap (i could tolerate it but couldn't find a mask that fit my face), as long as you put paper tape around the edges. My ahi went down to close to 0 with tape, whereas in the packing insert (without using paper tape) it's pretty high.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5066350
• MDR Report Key: 6128964
• Date Received: 2016-11-23
• Date of Report: 2016-11-23
• Date of Event: 2016-11-22
• Date Added to Maude: 2016-11-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: PROVENT SLEEP APNEA THERAPY
• Generic Name: PROVENT SLEEP APNEA THERAPY
• Product Code: OHP
• Date Received: 2016-11-23
• Lot Number: 34389
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PROVENT SLEEP THERAPY

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-11-23