MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-01 for PROVENT SLEEP THERAPY CAT1114 manufactured by Provent Sleep Therapy, Llc.
[74253395]
Device was manufactured to specification. No abnormalities noted.
Patient Sequence No: 1, Text Type: N, H10
[74253396]
User noticed the valve flaps missing from the device upon waking in the morning. It is unknown whether the device was defective before use or if the flaps detached during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011683122-2017-00001 |
| MDR Report Key | 6534628 |
| Date Received | 2017-05-01 |
| Date of Report | 2017-05-01 |
| Date of Event | 2016-05-01 |
| Date Mfgr Received | 2016-05-12 |
| Device Manufacturer Date | 2015-09-29 |
| Date Added to Maude | 2017-05-01 |
| 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 | 3 |
| Manufacturer Contact | MS. MELISSA CUNNIFFE |
| Manufacturer Street | 125 TOLMAN AVENUE |
| Manufacturer City | LEOMINSTER MA 01453 |
| Manufacturer Country | US |
| Manufacturer Postal | 01453 |
| Manufacturer Phone | 8887579355 |
| Manufacturer G1 | PROVENT SLEEP THERAPY, LLC |
| Manufacturer Street | 125 TOLMAN AVENUE |
| Manufacturer City | LEOMINSTER MA 01453 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01453 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROVENT SLEEP THERAPY |
| Generic Name | PROVENT 30 NIGHT STARTER KIT |
| Product Code | OHP |
| Date Received | 2017-05-01 |
| Returned To Mfg | 2016-05-27 |
| Model Number | CAT1114 |
| Catalog Number | CAT1114 |
| Lot Number | 34061-S07 |
| Device Expiration Date | 2018-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROVENT SLEEP THERAPY, LLC |
| Manufacturer Address | 125 TOLMAN AVENUE LEOMINSTER MA 01453 US 01453 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-01 |