MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-11 for SPIRATION VALVE SYSTEM, VALVE IN CARTRIDGE REF-HUS-V7 manufactured by Spiration, Inc..
[5421356]
Pt 9 had spiration valves placed on (b)(6) 2014 for treatment of pneumothorax due to severe bullous disease. At (b)(6) 2014 follow-up appointment, pt had bad cough (of one-week duration with increasing intensity), wheezing, and chest tightness (stabbing back and chest pain). Due to the severe pain with coughing, low blood pressure, and dizziness, physicians thought it best to admit the pt. On (b)(6) 2014, physician who placed the valves removed them.
Patient Sequence No: 1, Text Type: D, B5
[12760387]
Spiration reviewed device labeling (instructions for use and pt brochure) and confirmed that: the device was used off-label and the adverse events are anticipated (a long-lasting cough and severe problems that may require medical treatment). Method: reviewed report sent to (b)(4) by physician on (b)(6) 2014, (b)(4) conclusion dated (b)(4) 2014, physician's follow-up report dated (b)(6) 2014, and email communications with site research coordinator. In email dated (b)(6) 2014, it was indicated that physician thought the pt's symptoms were related to the spiration valves. On (b)(4) 2014, the (b)(4) concluded that the adverse event was not an unanticipated problem involving risks to subject or others.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004450998-2014-00001 |
| MDR Report Key | 4435568 |
| Report Source | 05 |
| Date Received | 2014-12-11 |
| Date of Report | 2014-12-11 |
| Date of Event | 2014-11-17 |
| Date Mfgr Received | 2014-11-17 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2015-01-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CYNDY ADAMS |
| Manufacturer Street | 6675 185TH AVENUE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254971700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIRATION VALVE SYSTEM, VALVE IN CARTRIDGE |
| Generic Name | ONE-WAY AIR LEAK VALVE |
| Product Code | OAZ |
| Date Received | 2014-12-11 |
| Model Number | REF-HUS-V7 |
| Lot Number | W05905-01, W06125-01 |
| Device Expiration Date | 2016-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIRATION, INC. |
| Manufacturer Address | 6675 185TH AVENUE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-12-11 |